Zimmer Biomet Hip Fracture Nail Recall: Set Screw Malfunction Risk
Zimmer Biomet recalls specific hip fracture nail models due to set screw failure. Affected items may not advance or reverse properly, potentially causing improper fixation.
Lower-risk recall
The set screw is not able to advance or reverse from the original position in the nail.
Contact the company
What happened, in plain English
Zimmer Biomet is recalling certain hip fracture nail models because the set screw can't properly advance or reverse. This could lead to improper bone fixation and increased risk of complications after surgery. Read more at govinfonow.com/recall/70425-zimmer-biomet-hip-fracture-nail-recall-set-screw-malfunction-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/70425-zimmer-biomet-hip-fracture-nail-recall-set-screw-malfunction-risk · Updated August 20, 2026 · FDA enforcement record: FDA #Z-3053-2018
Cite this page
“Zimmer Biomet Hip Fracture Nail Recall: Set Screw Malfunction Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/70425-zimmer-biomet-hip-fracture-nail-recall-set-screw-malfunction-risk. Based on FDA recall #Z-3053-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3053-2018%22&limit=1).
Why it’s dangerous
The set screw in the nail fails to move forward or backward from its starting position. This prevents the nail from securing properly to the bone, which could cause improper healing or displacement after surgery.
Who’s affected
Surgical patients who received the recalled hip fracture nail models during procedures. Patients using the specific model numbers are most at risk.
How to tell if you have this one
Check for the model name 'Affixus Hip Fracture Nail Right 125' with dimensions 9 mm x 440 mm. The item number 814309440 or 814090/899810 indicates the recalled product.
- Brand
Zimmer Biomet- Category
Medical device
All 129 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-3046-2018 | Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 280 mm, Item Number: 814309280; 331370 500240 | 5947 total |
| Z-3047-2018 | Affixus¿ Hip Fracture Nail 125¿ 9 mm x 180 mm, Item Number: 814309180; 017090 017100 017110 017120 063130 063190 188050 188080 188090 219720 219730 219740 219750 290520 290550 331360 371020 371060 455870 455890 530040 530060 530080 541100 559250 559260 559270 559290 688160 706780 899800 944420 530030 530090 | 5947 total |
| Z-3048-2018 | Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 300 mm, Item Number 814309300; 017130 052890 052910 | 5947 total |
| Z-3049-2018 | Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 320 mm, Item Number: 814309320; 789980 | 5947 total |
| Z-3050-2018 | Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 360 mm, Item Number: 814309360; 050830 052950 417420 | 5947 total |
| Z-3051-2018 | Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 380 mm, Item Number: 814309380; 814250 | 5947 total |
| Z-3052-2018 | Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 420 mm, Item Number: 814309420; 151830 886880 | 5947 total |
| Z-3053-2018 | Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 440 mm, Item Number: 814309440; 814090 899810 | 5947 total |
| Z-3054-2018 | Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 460 mm, Item Number: 814309460; 097120 767700 | 5947 total |
| Z-3055-2018 | Affixus¿ Hip Fracture Nail 125¿ 11 mm x 180 mm, Item Number: 814311180; 017190 017200 017210 017240 017260 063270 063330 063360 063370 063400 087850 087870 097080 132740 153330 153470 153490 153510 153540 219770 219780 290570 290580 290620 500680 500710 500740 503300 503350 519650 565790 565800 585690 601380 628190 645550 645580 688170 688190 688200 688210 707670 741680 741690 741700 899820 899840 899850 899870 899880 900000 | 5947 total |
| Z-3056-2018 | Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 280 mm, Item Number: 814311280; 500770 790170 | 5947 total |
| Z-3057-2018 | Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 300 mm, Item Number: 814311300; 132800 | 5947 total |
| Z-3058-2018 | Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 320 mm, Item Number: 814311320; 900040 | 5947 total |
| Z-3059-2018 | Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 340 mm, Item Number: 814311340; 152960 331460 456050 944450 | 5947 total |
| Z-3060-2018 | Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 360 mm, Item Number: 814311360; 132900 150870 331470 773070 688290 | 5947 total |
| Z-3061-2018 | Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 380 mm, Item Number: 814311380; 132920 188120 331480 688320 814070 | 5947 total |
| Z-3062-2018 | Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 400 mm, Item Number: 814311400; 097130 245980 417450 519300 854260 645620 645650 | 5947 total |
| Z-3063-2018 | Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 420 mm, Item Number: 814311420; 060900 331520 417460 645670 688350 017270 | 5947 total |
| Z-3064-2018 | Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 440 mm, Item Number: 814311440; 050850 155250 500840 541270 559240 | 5947 total |
| Z-3065-2018 | Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 460 mm, Item Number: 814311460; 017290 063450 155220 500860 | 5947 total |
| Z-3066-2018 | Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 180 mm, Item Number: 814313180; 060870 063550 063560 063570 114480 645700 900100 900250 944470 500880 | 5947 total |
| Z-3067-2018 | Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 260 mm, Item Number: 814313260; 053670 813260 | 5947 total |
| Z-3068-2018 | Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 280 mm, Item Number: 814313280; 053750 813300 | 5947 total |
| Z-3069-2018 | Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 300 mm, Item Number: 814313300; 645720 | 5947 total |
| Z-3070-2018 | Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 320 mm, Item Number: 814313320; 331530 971020 | 5947 total |
| Z-3071-2018 | Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 340 mm, Item Number: 814313340; 133040 188240 645750 | 5947 total |
| Z-3072-2018 | Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 360 mm, Item Number: 814313360; 050870 501210 645770 | 5947 total |
| Z-3073-2018 | Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 380 mm, Item Number: 814313380; 482620 501270 813390 | 5947 total |
| Z-3074-2018 | Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 400 mm, Item Number: 814313400; 501350 | 5947 total |
| Z-3075-2018 | Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 420 mm,Item Number: 814313420; 017300 097020 559190 | 5947 total |
| Z-3076-2018 | Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 440 mm, Item Number: 814313440; 155200 502270 051080 | 5947 total |
| Z-3077-2018 | Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 460 mm, Item Number: 814313460; 083760 017310 | 5947 total |
| Z-3078-2018 | Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 260 mm, Item Number: 814409260; 971030 | 5947 total |
| Z-3079-2018 | Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 280 mm, Item Number: 814409280; 707700 | 5947 total |
| Z-3080-2018 | Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 300 mm, Item Number: 814409300; 133160 790790 | 5947 total |
| Z-3081-2018 | Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 320 mm, Item Number: 814409320; 114560 133170 | 5947 total |
| Z-3082-2018 | Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 340 mm, Item Number: 814409340; 212940 503520 565820 645800 971050 | 5947 total |
| Z-3083-2018 | Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 360 mm, Item Number: 814409360; 097140 133190 144070 | 5947 total |
| Z-3084-2018 | Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 380 mm, Item Number: 814409380; 053790 155180 762720 790780 813530 | 5947 total |
| Z-3085-2018 | Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 400 mm, Item Number: 814409400; 051130 053810 133200 153200 813940 097150 767720 | 5947 total |
| Z-3086-2018 | Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 420 mm, Item Number: 814409420; 503570 790820 | 5947 total |
| Z-3087-2018 | Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 440 mm, Item Number: 814409440; 503610 900270 | 5947 total |
| Z-3088-2018 | Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 460 mm, Item Number: 814409460; 097160 133230 | 5947 total |
| Z-3089-2018 | Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 260 mm, Item Number: 814411260; 503640 | 5947 total |
| Z-3090-2018 | Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 320 mm, Item Number: 814411320; 155130 813600 | 5947 total |
| Z-3091-2018 | Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 340 mm, Item Number: 814411340; 530180 585810 | 5947 total |
| Z-3092-2018 | Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 360 mm, Item Number: 814411360; 503700 646540 707750 519470 | 5947 total |
| Z-3093-2018 | Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 380 mm, Item Number: 814411380; 053940 813860 886990 | 5947 total |
| Z-3094-2018 | Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 400 mm, Item Number: 814411400; 053980 053990 646590 768010 530100 646600 | 5947 total |
| Z-3095-2018 | Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 420 mm, Item Number: 814411420; 155120 245960 472890 813680 813860 | 5947 total |
| Z-3096-2018 | Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 440 mm, Item Number: 814411440; 151870 155110 646620 960600 646630 646640 | 5947 total |
| Z-3097-2018 | Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 460 mm, Item Number: 814411460; 054000 097060 285050 287410 | 5947 total |
| Z-3098-2018 | Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 260 mm, Item Number: 814413260; 814090 | 5947 total |
| Z-3099-2018 | Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 280 mm, Item Number: 814413280; 559130 | 5947 total |
| Z-3100-2018 | Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 300 mm, Item Number: 814413300; 331610 | 5947 total |
| Z-3101-2018 | Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 320 mm, Item Number: 814413320; 245830 331620 | 5947 total |
| Z-3102-2018 | Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 340 mm, Item Number: 814413340; 482730 155980 156040 | 5947 total |
| Z-3103-2018 | Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 360 mm, Item Number: 814413360; 054030 054040 312200 312210 | 5947 total |
| Z-3104-2018 | Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 380 mm, Item Number: 814413380; 417480 646660 | 5947 total |
| Z-3105-2018 | Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 400 mm, Item Number: 814413400; 054100 646680 | 5947 total |
| Z-3106-2018 | Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 420 mm, Item Number: 814413420; 155080 156070 156150 482640 762730 | 5947 total |
| Z-3107-2018 | Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 460 mm, Item Number: 814413460; 155070 | 5947 total |
| Z-3108-2018 | Affixus¿ Hip Fracture Nail 130¿ 9 mm x 180 mm, Item Number: 814509180; 054130 085710 144520 150790 156740 156750 219790 245740 245820 287290 287400 456140 482650 707780 900280 944590 944630 944640 970640 609640 609650 | 5947 total |
| Z-3109-2018 | Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 260 mm, Item Number: 814509260; 813650 | 5947 total |
| Z-3110-2018 | Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 280 mm, Item Number: 814509280; 768020 | 5947 total |
| Z-3111-2018 | Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 300 mm, Item Number: 814509300; 212980 128150 971560 | 5947 total |
| Z-3112-2018 | Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 320 mm, Item Number: 814509320; 530190 887000 971580 | 5947 total |
| Z-3113-2018 | Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 340 mm, Item Number: 814509340; 503940 646730 | 5947 total |
| Z-3114-2018 | Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 360 mm, Item Number: 814509360; 813470 646750 | 5947 total |
| Z-3115-2018 | Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 380 mm, Item Number: 814509380; 628920 646790 773060 | 5947 total |
| Z-3116-2018 | Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 400 mm, Item Number: 814509400; 646830 900740 | 5947 total |
| Z-3117-2018 | Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 420 mm, Item Number: 814509420; 153010 159190 707830 503950 503960 | 5947 total |
| Z-3118-2018 | Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 440 mm, Item Number: 814509440; 054150 054170 130740 130750 188310 519480 472970 503970 | 5947 total |
| Z-3119-2018 | Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 460 mm, Item Number: 814509460; 254720 017420 960610 | 5947 total |
| Z-3120-2018 | Affixus¿ Hip Fracture Nail 130¿ 11 mm x 180 mm, Item Number: 814511180; 072620 130760 130770 130780 130790 130800 130810 130820 130840 130850 130860 130900 130920 131030 156770 157000 188340 219800 219810 219820 219910 245570 245690 287090 287120 287130 371170 456160 519490 530110 530120 530130 558980 565870 565880 601390 707920 768050 772730 854270 901300 901330 901350 901360 901370 901380 901400 901410 944660 944720 970790 970810 970820 970830 970840 970850 970860 970870 970880 970890 130930 130940 156970 503980 503990 504000 504010 | 5947 total |
| Z-3121-2018 | Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 260 mm, Item Number: 814511260; 791640 813460 | 5947 total |
| Z-3122-2018 | Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 280 mm, Item Number: 814511280; 155000 483480 646910 646930 646950 353610 | 5947 total |
| Z-3123-2018 | Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 300 mm, Item Number: 814511300; 558960 | 5947 total |
| Z-3124-2018 | Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 320 mm, Item Number: 814511320; 331650 | 5947 total |
| Z-3125-2018 | Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 340 mm, Item Number: 814511340; 054180 483490 519590 558900 558910 586640 371200 | 5947 total |
| Z-3126-2018 | Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 360 mm, Item Number: 814511360; 107830 107850 152910 154990 482740 519610 565900 707960 762780 773410 812310 812330 097190 696380 | 5947 total |
| Z-3127-2018 | Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 380 mm, Item Number: 814511380; 054200 054210 054220 519620 519630 813210 | 5947 total |
| Z-3128-2018 | Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 400 mm, Item Number: 814511400; 054240 054250 154980 472860 773390 798600 798610 017490 245530 | 5947 total |
| Z-3129-2018 | Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 420 mm, Item Number: 814511420; 154960 558870 558880 628930 707860 171860 171870 | 5947 total |
| Z-3130-2018 | Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 440 mm, Item Number: 814511440; 213000 558850 | 5947 total |
| Z-3131-2018 | Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 460 mm, Item Number: 814511460; 157130 558840 710910 | 5947 total |
| Z-3132-2018 | Affixus¿ Hip Fracture Nail 130¿ 13 mm x 180 mm, Item Number: 814513180; 063590 063600 220020 245510 290720 371210 482750 482760 482770 523410 097180 188350 188370 290690 970510 970530 970580 | 5947 total |
| Z-3133-2018 | Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 260 mm, Item Number: 814513260; 901420 | 5947 total |
| Z-3134-2018 | Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 280 mm, Item Number: 814513280; 213010 707970 944730 | 5947 total |
| Z-3135-2018 | Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 300 mm, Item Number: 814513300; 944850 | 5947 total |
| Z-3136-2018 | Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 340 mm, Item Number: 814513340; 017700 | 5947 total |
| Z-3137-2018 | Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 380 mm, Item Number: 814513380; 587670 707980 711060 | 5947 total |
| Z-3138-2018 | Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 400 mm, Item Number: 814513400; 152980 482780 530160 798520 798530 798540 773050 | 5947 total |
| Z-3139-2018 | Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 420 mm, Item Number: 814513420; 060800 060820 397280 397290 397300 812970 901490 418360 | 5947 total |
| Z-3140-2018 | Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 440 mm, Item Number: 814513440; 154920 711080 017710 | 5947 total |
| Z-3141-2018 | Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 460 mm, Item Number: 814513460; 558790 711090 901520 | 5947 total |
| Z-3142-2018 | Affixus¿ Hip Fracture Nail Right 130¿ 15 mm x 320 mm, Item Number: 814515320; 154900 818440 | 5947 total |
| Z-3143-2018 | Affixus¿ Hip Fracture Nail Right 130¿ 15 mm x 360 mm, Item Number: 814515360; 154890 814740 | 5947 |
| Z-3144-2018 | Affixus¿ Hip Fracture Nail Right 130¿ 15 mm x 400 mm, Item Number: 814515400; 364250 | 5947 total |
| Z-3145-2018 | Affixus¿ Hip Fracture Nail Right 130¿ 15 mm x 440 mm, Item Number: 814515440; 154880 | 5947 total |
| Z-3146-2018 | Affixus¿ Hip Fracture Nail Left 130¿ 9 mm x 260 mm, Item Number: 814609260; 157170 | 5947 total |
| Z-3147-2018 | Affixus¿ Hip Fracture Nail Left 130¿ 9 mm x 280 mm, Item Number: 814609280; 107860 558680 791850 091560 | 5947 total |
| Z-3148-2018 | Affixus¿ Hip Fracture Nail Left 130¿ 9 mm x 320 mm, Item Number: 814609320; 055260 154870 721080 | 5947 total |
| Z-3149-2018 | Affixus¿ Hip Fracture Nail Left 130¿ 9 mm x 360 mm, Item Number: 814609360; 287140 | 5947 total |
| Z-3150-2018 | Affixus¿ Hip Fracture Nail Left 130¿ 9 mm x 400 mm, Item Number: 814609400; 055360 055510 157290 917700 972060 812750 812920 812930 | 5947 total |
| Z-3151-2018 | Affixus¿ Hip Fracture Nail Left 130¿ 9 mm x 420 mm, Item Number: 814609420; 762840 | 5947 total |
| Z-3152-2018 | Affixus¿ Hip Fracture Nail Left 130¿ 9 mm x 460 mm, Item Number: 814609460; 055580 154820 154830 245470 | 5947 total |
| Z-3153-2018 | Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 260 mm, Item Number: 814611260; 091610 558640 629150 | 5947 total |
| Z-3154-2018 | Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 280 mm, Item Number: 814611280; 711150 711170 | 5947 total |
| Z-3155-2018 | Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 320 mm, Item Number: 814611320; 331940 558590 900100 | 5947 total |
| Z-3156-2018 | Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 340 mm, Item Number: 814611340; 154800 154810 155350 629170 157430 587790 944920 | 5947 total |
| Z-3157-2018 | Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 360 mm, Item Number: 814611360; 017730 085400 154660 154670 154680 157450 558510 565960 694270 711210 812570 812730 818350 945040 629800 | 5947 total |
| Z-3158-2018 | Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 380 mm, Item Number: 814611380; 152900 154610 901540 901550 901560 901570 901580 901590 901600 565970 609690 | 5947 total |
| Z-3159-2018 | Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 400 mm, Item Number: 814611400; 060780 154560 482790 530170 759190 797000 797020 812460 812540 759180 | 5947 total |
| Z-3160-2018 | Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 420 mm, Item Number: 814611420; 154540 155340 712170 791890 712240 812340 | 5947 total |
| Z-3161-2018 | Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 440 mm, Item Number: 814611440; 558490 759400 | 5947 total |
| Z-3162-2018 | Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 460 mm, Item Number: 814611460; 171830 712290 | 5947 total |
| Z-3163-2018 | Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 260 mm, Item Number: 814613260; 171820 972190 | 5947 total |
| Z-3164-2018 | Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 280 mm, Item Number: 814613280; 688510 763000 | 5947 total |
| Z-3165-2018 | Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 300 mm, Item Number: 814613300; 818430 960660 | 5947 total |
| Z-3166-2018 | Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 320 mm, Item Number: 814613320; 245390 287180 | 5947 total |
| Z-3167-2018 | Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 340 mm, Item Number: 814613340; 331960 | 5947 total |
| Z-3168-2018 | Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 360 mm, Item Number: 814613360; 816070 091850 | 5947 total |
| Z-3169-2018 | Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 380 mm, Item Number: 814613380; 712320 145040 | 5947 total |
| Z-3170-2018 | Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 400 mm, Item Number: 814613400; 055730 060770 154510 558410 712370 543380 | 5947 total |
| Z-3171-2018 | Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 420 mm, Item Number: 814613420; 154480 482820 | 5947 total |
| Z-3172-2018 | Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 440 mm, Item Number: 814613440; 157490 482830 | 5947 total |
| Z-3173-2018 | Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 460 mm, Item Number: 814613460; 055760 154460 503740 558390 712400 | 5947 total |
| Z-3174-2018 | Affixus¿ Hip Fracture Nail Left 130¿ 15 mm x 360 mm, Item Number: 814615360; 154450 791930 | 5947 total |
What to do — step by step
Check Product Details
Verify the model name, dimensions, and item number to confirm if your nail is recalled.
Where it went and when
Where it was distributed
Distributed in 41 states and Puerto Rico, and outside the U.S.
FDA distribution: “The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico.…” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Arizona, Arkansas, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, Wyoming.
Recall timeline
FDA terminated this recall 23 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-3053-2018 (July 17, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3053-2018 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.