Lower risk Medical device recall · FDA · Published August 7, 2017
Zimmer Biomet Affixus Hip Fracture Nail Recall: Assembly Issue
Zimmer Biomet recalls Affixus Hip Fracture Nails with potential assembly issues that could prevent proper function during hip fracture repair.
Lower-risk recall
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
Contact the company
Recalling firmZimmer Biomet, Inc.56 E Bell Dr · Warsaw, IN 46582-6989
What happened, in plain English
Zimmer Biomet is recalling certain Affixus Hip Fracture Nails due to a potential assembly problem that might prevent the nail from working correctly with the matching screw and targeting jig during hip fracture surgery. Read more at govinfonow.com/recall/73162-zimmer-biomet-affixus-hip-fracture-nail-recall-assembly-issue.
Source Summary by GovInfoNow · govinfonow.com/recall/73162-zimmer-biomet-affixus-hip-fracture-nail-recall-assembly-issue · Updated September 18, 2026 · FDA enforcement record: FDA #Z-0420-2018
Cite this page
“Zimmer Biomet Affixus Hip Fracture Nail Recall: Assembly Issue.” GovInfoNow, updated September 18, 2026. https://govinfonow.com/recall/73162-zimmer-biomet-affixus-hip-fracture-nail-recall-assembly-issue. Based on FDA recall #Z-0420-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0420-2018%22&limit=1).
Why it’s dangerous
The set screw and sleeve assembly in the nail may no longer be in the correct position after manufacturing. This could prevent the nail from properly connecting with the matching screw and targeting jig during surgery, potentially leading to improper fixation of the hip fracture.
Who’s affected
Surgical teams using the recalled Affixus Hip Fracture Nails for hip fracture repairs are affected. Patients undergoing hip fracture surgery with these specific nails are at risk of improper fixation.
How to tell if you have this one
Check for the product name 'Affixus Hip Fracture Nail', size 125 DEG 11MM X 180MM. Look for item number 814311180 and lot number 459190 with an expiration date of 05/17/2027.
- Brand
Zimmer Biomet- Product
Affixus Hip Fracture Nail, 125 DEG 11MM X 180MM- Category
Medical device
All 65 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
US nationwide distribution. Also Portugal and the Netherlands.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0420-2018 | Affixus Hip Fracture Nail, 125 DEG 11MM X 180MM; Item No. 814311180, Lot No. 459190, Exp. Date 05/17/2027, (01)00887868038082 (17)270517 (10)459190 | 638 units |
| Z-0421-2018 | Affixus Hip Fracture Nail, 125 DEG 9MM X 180MM; Item No. 814309180, Lot No. 459250, Exp. Date 05/27/2027, UDI (01)00887868037962 (17)270527 (10)459250 | 638 units |
| Z-0422-2018 | Affixus Hip Fracture Nail, 130 DEG 11MM X 180MM; Item No. 814511180, Lot No. 459170, Exp. Date 05/18/2027, (01)00887868039102 (17)270518 (10)459170 | 638 units |
| Z-0423-2018 | Affixus Hip Fracture Nail, 130 DEG 9MM X 180MM; Item No. 814509180, Lot No. 459290, Exp. Date 05/17/2027, (01)00887868038846 (17)270517 (10)459290 | 638 units |
| Z-0424-2018 | Affixus Hip Fracture Nail, LH 125 DEG 11MM X 320MM; Item No. 814411320; Lot No. (Exp. Date) UDI: 459230 (05/19/2027) UDI (01)00887868038464 (17)270519 (10)459230, 701830 (06/03/2027) UDI (01)00887868038464 (17)270603 (10)701830, 893480 (06/12/2027) UDI (01) 00887868038464 (17)270612 (10)893480 | 638 units |
| Z-0425-2018 | Affixus Hip Fracture Nail, LH 125 DEG 11MM X 360MM; Item No. 814411360; Lot No. 935900; Exp. Date 06/15/2027, UDI (01)00887868038488 (17)270615 (10)935900 | 638 units |
| Z-0426-2018 | Affixus Hip Fracture Nail, LH 125 DEG 11MM X 440MM; Item No. 814411440; Lot No. 459240; Exp. Date 05/21/2027, UDI (01)00887868038525 (17)270521 (10)459240 | 638 units |
| Z-0427-2018 | Affixus Hip Fracture Nail, LH 125 DEG 9MM X 260MM; Item No. 814409260; Lot No. 936020; Exp. Date 06/15/2027, UDI (01)00887868038327 (17)270615 (10)936020 | 638 units |
| Z-0428-2018 | Affixus Hip Fracture Nail, LH 125 DEG 9MM X 340MM; Item No. 814409340; Lot No. (Exp. Date) UDI: 581630 (06/03/2027 UDI (01)00887868038365 (17)270603 (10)581630; 942020 (06/16/2027) UDI (01)00887868038365 (17)270616 (10)942020 | 638 units |
| Z-0429-2018 | Affixus Hip Fracture Nail, LH 125 DEG 9MM X 380MM; Item No. 814409380; Lot No. (Exp. Date) UDI: 398590 (05/19/2027 UDI (01)00887868038389 (17)270519 (10)398590; 702190 (06/04/2027) UDI (01)00887868038389 (17)270604 (10)702190 | 638 units |
| Z-0430-2018 | Affixus Hip Fracture Nail, LH 125 DEG 9MM X 440MM; Item No. 814409440; Lot No. (Exp. Date) UDI: 936140 (06/15/2027 UDI (01)00887868038419 (17)270615 (10)936140 | 638 units |
| Z-0431-2018 | Affixus Hip Fracture Nail, LH 130 DEG 11MM X 260MM; Item No. 814611260; Lot No. (Exp. Date) UDI: 507350 (05/21/2027 UDI (01)00887868039768 (17)270521 (10)507350; 701700 (06/05/2027) UDI (01)00887868039768 (17)270605 (10)701700; 701720 (06/05/2027) UDI (01)00887868039768 (17)270605 (10)701720; 701780 (06/05/2027) UDI (01)00887868039768 (17)270605 (10)701780 | 638 units |
| Z-0432-2018 | Affixus Hip Fracture Nail, LH 130 DEG 11MM X 280MM; Item No. 814611280; Lot No. (Exp. Date) UDI: 459270 (05/18/2027) UDI (01)00887868039775 (17)270518 (10)459270; 858780 (06/16/2027) UDI (01)00887868039775 (17)270616 (10)858780; 972840 (06/15/2027) UDI (01)00887868039775 (17)270615 (10)972840 | 638 units |
| Z-0433-2018 | Affixus Hip Fracture Nail, LH 130 DEG 11MM X 300MM; Item No. 81461130; Lot No. (Exp. Date) UDI: 406280 (05/19/2027) UDI (01)00887868039782 (17)270519 (10)406280; 972900 (06/16/2027) UDI (01)00887868039782 (17)270616 (10)972900 | 638 units |
| Z-0434-2018 | Affixus Hip Fracture Nail, LH 130 DEG 11MM X 340MM; Item No. 814611340; Lot No. (Exp. Date) UDI: 535240 (05/24/2027) UDI (01)00887868039805 (17)270524 (10)535240 | 638 units |
| Z-0435-2018 | Affixus Hip Fracture Nail, LH 130 DEG 11MM X 380MM; Item No. 814611380; Lot No. (Exp. Date) UDI: 555730 (05/24/2027) UDI (01)00887868039829 (17)270524 (10)555730 | 638 units |
| Z-0436-2018 | Affixus Hip Fracture Nail, LH 130 DEG 11MM X 400MM; Item No. 814611400; Lot No. (Exp. Date) UDI: 582380 (05/29/2027) UDI (01)00887868039836 (17)270529 (10)582380; 702230 (06/04/2027) UDI (01)00887868039836 (17)270604 (10)702230 | 638 Units |
| Z-0437-2018 | Affixus Hip Fracture Nail, LH 130 DEG 11MM X 420MM; Item No. 814611420; Lot No. (Exp. Date) UDI: 535690 (05/30/2027) UDI (01)00887868039843 (17)270530 (10)535690 | 638 units |
| Z-0438-2018 | Affixus Hip Fracture Nail, LH 130 DEG 11MM X 440MM; Item No. 814611440; Lot No. (Exp. Date) UDI: 858840 (06/14/2027) UDI (01)00887868039850 (17)270614 (10)858840 | 638 units |
| Z-0439-2018 | Affixus Hip Fracture Nail, LH 130 DEG 11MM X 460MM; Item No. 814611460; Lot No. (Exp. Date) UDI: 555810 (05/27/2027) UDI (01)00887868039867 (17)270527 (10)555810; 788580 (07/17/2027) UDI (01)00887868039867 (17)270717 (10)788580 | 638 units |
| Z-0440-2018 | Affixus Hip Fracture Nail, LH 130 DEG 13MM X 460MM; Item No. 814613460; Lot No. (Exp. Date) UDI: 862150 (06/15/2027) UDI (01)00887868039980 (17)270615 (10)862150 | 638 units |
| Z-0441-2018 | Affixus Hip Fracture Nail, LH 130 DEG 9MM X 280MM; Item No. 814609280; Lot No. (Exp. Date) UDI: 936100 (06/15/2027) UDI (01)00887868039669 (17)270615 (10)936100 | 638 units |
| Z-0442-2018 | Affixus Hip Fracture Nail, LH 130 DEG 9MM X 300MM; Item No. 814609300; Lot No. (Exp. Date) UDI: 595480 (05/28/2027) UDI (01)00887868039676 (17)270528 (10)595480; 788380 (06/15/2027) UDI (01)00887868039676 (17)270615 (10)788380; 973000 (07/10/2027) UDI (01)00887868039676 (17)270710 (10)973000 | 638 units |
| Z-0443-2018 | Affixus Hip Fracture Nail, LH 130 DEG 9MM X 320MM; Item No. 814609320; Lot No. (Exp. Date) UDI: 535150 (05/24/2027) UDI (01)00887868039683 (17)270524 (10)535150; 942050 (06/15/2027) UDI (01)00887868039683 (17)270615 (10)942050 | 638 units |
| Z-0444-2018 | Affixus Hip Fracture Nail, LH 130 DEG 9MM X 340MM; Item No. 814609340; Lot No. (Exp. Date) UDI: 535230 (05/24/2027) UDI (01)00887868039690 (17)270524 (10)535230 | 638 units |
| Z-0445-2018 | Affixus Hip Fracture Nail, LH 130 DEG 9MM X 400MM; Item No. 814609400; Lot No. (Exp. Date) UDI: 480330 (05/19/2027) UDI (01)00887868039720 (17)270519 (10)480330; 701940 (06/03/2027) UDI (01)00887868039720 (17)270603 (10)701940; 858970 (06/14/2027) UDI (01)00887868039720 (17)270614 (10)858970 | 638 units |
| Z-0446-2018 | Affixus Hip Fracture Nail, LH 130 DEG 9MM X 420MM; Item No. 814609420; Lot No. (Exp. Date) UDI: 438040 (05/22/2027) UDI (01)00887868039737 (17)270522 (10)438040; 701640 (06/04/2027) UDI (01)00887868039737 (17)270604 (10)701640 | 638 units |
| Z-0447-2018 | Affixus Hip Fracture Nail, LH 130 DEG 9MM X 440MM; Item No. 814609440; Lot No. (Exp. Date) UDI: 507340 (05/22/2027) UDI (01)00887868039744 (17)270522 (10)507340; 858900 (06/14/2027) UDI (01)00887868039744 (17)270614 (10)858900 | 638 units |
| Z-0448-2018 | Affixus Hip Fracture Nail, RH 125 DEG 11MM X 300MM; Item No. 814344300; Lot No. (Exp. Date) UDI: 459160 (05/18/2027) UDI (01)00887868038112 (17)270518 (10)459160; 893470 (06/16/2027) UDI (01)00887868038112 (17)270616 (10)893470 | 638 units |
| Z-0449-2018 | Affixus Hip Fracture Nail, RH 125 DEG 11MM X 380MM; Item No. 814311380; Lot No. (Exp. Date) UDI: 459200 (05/18/2027) UDI (01)00887868038150 (17)270518 (10)459200 | 638 units |
| Z-0450-2018 | Affixus Hip Fracture Nail, RH 125 DEG 11MM X 440MM; Item No. 814311440; Lot No. (Exp. Date) UDI: 666800 (06/16/2027) UDI (01)00887868038181 (17)270616 (10)666800 | 638 units |
| Z-0451-2018 | Affixus Hip Fracture Nail, RH 125 DEG 11MM X 460MM; Item No. 814311460; Lot No. (Exp. Date) UDI: 788650 (06/05/2027) UDI (01)00887868038198 (17)270605 (10)788650 | 638 units |
| Z-0452-2018 | Affixus Hip Fracture Nail, RH 125 DEG 13MM X 260MM; Item No. 814313260; Lot No. (Exp. Date) UDI: 760270 (06/12/2027) UDI (01)00887868038211 (17)270612 (10)760270 | 638 units |
| Z-0453-2018 | Affixus Hip Fracture Nail, RH 125 DEG 13MM X 320MM; Item No. 814313320; Lot No. (Exp. Date) UDI: 788630 (06/05/2027) UDI (01)00887868038242 (17)270605 (10)788630 | 638 units |
| Z-0454-2018 | Affixus Hip Fracture Nail, RH 125 DEG 9MM X 260MM; Item No. 814309260; Lot No. (Exp. Date) UDI: 702050 (06/12/2027) UDI (01)00887868037979 (17)270612 (10)702050 | 638 units |
| Z-0455-2018 | Affixus Hip Fracture Nail, RH 125 DEG 9MM X 320MM; Item No. 814309320; Lot No. (Exp. Date) UDI: 669850 (06/15/2027) UDI (01)00887868038006 (17)270615 (10)669850; 737670 (06/14/2027) UDI (01)00887868038006 (17)270614 (10)737670 | 638 units |
| Z-0456-2018 | Affixus Hip Fracture Nail, RH 125 DEG 9MM X 340MM; Item No. 814309340; Lot No. (Exp. Date) UDI: 581620 (05/26/2027) UDI (01)00887868038013 (17)270526 (10)581620 | 638 units |
| Z-0457-2018 | Affixus Hip Fracture Nail, RH 125 DEG 9MM X 360MM; Item No. 814309360; Lot No. (Exp. Date) UDI: 788440 (06/15/2027) UDI (01)00887868038020 (17)270615 (10)788440; 788460 (06/07/2027) UDI (01)00887868038020 (17)270607 (10)788460 | 638 units |
| Z-0458-2018 | Affixus Hip Fracture Nail, RH 125 DEG 9MM X 400MM; Item No. 814309400; Lot No. (Exp. Date) UDI: 437960 (05/20/2027) UDI (01)00887868038044 (17)270520 (10)437960; 893070 (06/14/2027) UDI (01)00887868038044 (17)270614 (10)893070 | 638 units |
| Z-0459-2018 | Affixus Hip Fracture Nail, RH 125 DEG 9MM X 420MM; Item No. 814309420; Lot No. (Exp. Date) UDI: 935970 (06/15/2027) UDI (01)00887868038051 (17)270615 (10)935970 | 638 units |
| Z-0460-2018 | Affixus Hip Fracture Nail, RH 125 DEG 9MM X 440MM; Item No. 814309440; Lot No. (Exp. Date) UDI: 760030 (06/14/2027) UDI (01)00887868038068 (17)270614 (10)760030; 788620 (06/07/2027) UDI (01)00887868038068 (17)270607 (10)788620 | 638 units |
| Z-0461-2018 | Affixus Hip Fracture Nail, RH 125 DEG 9MM X 460MM; Item No. 814309460; Lot No. (Exp. Date) UDI: 737630 (06/14/2027) UDI (01)00887868038075 (17)270614 (10)737630 | 638 units |
| Z-0462-2018 | Affixus Hip Fracture Nail, RH 130 DEG 11MM X 260MM; Item No. 814511260; Lot No. (Exp. Date) UDI: 512520 (05/20/2027) UDI (01)00887868039119 (17)270520 (10)512520; 701810 (06/05/2027) UDI (01)00887868039119 (17)270605 (10)701810; 893460 (06/15/2027) UDI (01)00887868039119 (17)270615 (10)893460 | 638 units |
| Z-0463-2018 | Affixus Hip Fracture Nail, RH 130 DEG 11MM X 280MM; Item No. 814511280 ; Lot No. (Exp. Date) UDI: 893430 (06/15/2027) UDI (01)00887868039126 (17)270615 (10)893430; 893490 (06/15/2027) UDI (01)00887868039126 (17)270615 (10)893490 | 638 units |
| Z-0464-2018 | Affixus Hip Fracture Nail, RH 130 DEG 11MM X 300MM; Item No. 814511300; Lot No. (Exp. Date) UDI: 480070 (06/12/2027) UDI (01)00887868039133 (17)270612 (10)480070; 858790 (06/12/2027) UDI (01)00887868039133 (17)270612 (10)858790; 893450 (06/15/2027) UDI (01)00887868039133 (17)270615 (10)893450 | 638 units |
| Z-0465-2018 | Affixus Hip Fracture Nail, RH 130 DEG 11MM X 320MM; Item No. 814511320; Lot No. (Exp. Date) UDI: 480090 (05/18/2027) UDI (01)00887868039140 (17)270518 (10)480090; 893410 (06/12/2027) UDI (01)00887868039140 (17)270612 (10)893410; 942070 (07/17/2027) UDI (01)00887868039140 (17)270717 (10)942070 | 638 units |
| Z-0466-2018 | Affixus Hip Fracture Nail, RH 130 DEG 11MM X 340MM; Item No. 814511340; Lot No. (Exp. Date) UDI: 581910 (05/25/2027) UDI (01)00887868039157 (17)270525 (10)581910 | 638 units |
| Z-0467-2018 | Affixus Hip Fracture Nail, RH 130 DEG 11MM X 360MM; Item No. 814511360; Lot No. (Exp. Date) UDI: 555620 (05/24/2027) UDI (01)00887868039164 (17)270524 (10)555620 | 638 units |
| Z-0468-2018 | Affixus Hip Fracture Nail, RH 130 DEG 11MM X 380MM; Item No. 814511360; Lot No. (Exp. Date) UDI: 862170 (06/16/2027) UDI (01)00887868039171 (17)270616 (10)862170 | 638 units |
| Z-0469-2018 | Affixus Hip Fracture Nail, RH 130 DEG 11MM X 400MM; Item No. 814511400; Lot No. (Exp. Date) UDI: 507300 (05/21/2027) UDI (01)00887868039188 (17)270521 (10)507300 | 638 units |
| Z-0470-2018 | Affixus Hip Fracture Nail, RH 130 DEG 11MM X 420MM; Item No. 814511420; Lot No. (Exp. Date) UDI: 535130 (06/02/2027) UDI (01)00887868039195 (17)270602 (10)535130; 858960 (06/15/2027) UDI (01)00887868039195 (17)270615 (10)858960 | 638 units |
| Z-0471-2018 | Affixus Hip Fracture Nail, RH 130 DEG 11MM X 440MM; Item No. 814511440; Lot No. (Exp. Date) UDI: 507320 (05/21/2027) UDI (01)00887868039201 (17)270521 (10)507320 | 638 units |
| Z-0472-2018 | Affixus Hip Fracture Nail, RH 130 DEG 13MM X 280MM; Item No. 814513280; Lot No. (Exp. Date) UDI: 581960 (05/31/2027) UDI (01)00887868039263 (17)270531 (10)581960; 858740 (06/26/2027) UDI (01)00887868039263 (17)270626 (10)858740 | 638 units |
| Z-0473-2018 | Affixus Hip Fracture Nail, RH 130 DEG 13MM X 300MM; Item No. 814513300; Lot No. (Exp. Date) UDI: 581970 (06/01/2027) UDI (01)00887868039270 (17)270601 (10)581970; 942010 (06/24/2027) UDI (01)00887868039270 (17)270624 (10)942010 | 638 units |
| Z-0474-2018 | Affixus Hip Fracture Nail, RH 130 DEG 13MM X 440MM; Item No. 814513440; Lot No. (Exp. Date) UDI: 582240 (05/27/2027) UDI (01)00887868039348 (17)270527 (10)582240 | 638 units |
| Z-0475-2018 | Affixus Hip Fracture Nail, RH 130 DEG 13MM X 460MM; Item No. 814513460; Lot No. (Exp. Date) UDI: 582360 (05/26/2027) UDI (01)00887868039355 (17)270526 (10)582360 | 638 units |
| Z-0476-2018 | Affixus Hip Fracture Nail, RH 130 DEG 9MM X 260MM; Item No. 814509260; Lot No. (Exp. Date) UDI: 581640 (05/27/2027) UDI (01)00887868038853 (17)270527 (10)581640; 788410 (06/15/2027) UDI (01)00887868038853 (17)270615 (10)788410; 892940 (06/15/2027) UDI (01)00887868038853 (17)270615 (10)892940; 892950 (06/15/2027) UDI (01)00887868038853 (17)270615 (10)892950 | 638 units |
| Z-0477-2018 | Affixus Hip Fracture Nail, RH 130 DEG 9MM X 300MM; Item No. 814509300; Lot No. (Exp. Date) UDI: 581700 (05/27/2027) UDI (01)00887868038877 (17)270527 (10)581700 | 638 units |
| Z-0478-2018 | Affixus Hip Fracture Nail, RH 130 DEG 9MM X 320MM; Item No. 814509320; Lot No. (Exp. Date) UDI: 555180 (05/24/2027) UDI (01)00887868038884 (17)270524 (10)555180; 858640 (06/15/2027) UDI (01)00887868038884 (17)270615 (10)858640; 893090 (06/12/2027) UDI (01)00887868038884 (17)270612 (10)893090 | 638 units |
| Z-0479-2018 | Affixus Hip Fracture Nail, RH 130 DEG 9MM X 340MM; Item No. 814509340; Lot No. (Exp. Date) UDI: 535120 (05/24/2027) UDI (01)00887868038891 (17)270524 (10)535120; 893500 (06/12/2027) UDI (01)00887868038891 (17)270612 (10)893500 | 638 units |
| Z-0480-2018 | Affixus Hip Fracture Nail, RH 130 DEG 9MM X 360MM; Item No. 814509360; Lot No. (Exp. Date) UDI: 555460 (05/24/2027) UDI (01)00887868038907 (17)270524 (10)555460; 892960 (06/14/2027) UDI (01)00887868038907 (17)270614 (10)892960; 892990 (06/15/2027) UDI (01)00887868038907 (17)270615 (10)892990 | — |
| Z-0481-2018 | Affixus Hip Fracture Nail, RH 130 DEG 9MM X 380MM; Item No. 814509380; Lot No. (Exp. Date) UDI: 507130 (05/21/2027) UDI (01)00887868038914 (17)270521 (10)507130; 892880 (06/13/2027) UDI (01)00887868038914 (17)270613 (10)892880; 893400 (06/13/2027) UDI (01)00887868038914 (17)270613 (10)893400 | 638 units |
| Z-0482-2018 | Affixus Hip Fracture Nail, RH 130 DEG 9MM X 400MM; Item No. 814509400; Lot No. (Exp. Date) UDI: 480050 (05/21/2027) UDI (01)00887868038921 (17)270521 (10)480050; 701480 (06/03/2027) UDI (01)00887868038921 (17)270603 (10)701480; 701900 (06/03/2027) UDI (01)00887868038921 (17)270603 (10)701900 | 638 units |
| Z-0483-2018 | Affixus Hip Fracture Nail, RH 130 DEG 9MM X 420MM; Item No. 814509420; Lot No. (Exp. Date) UDI: 398610 (05/19/2027) UDI (01)00887868038938 (17)270519 (10)398610; 858830 (06/13/2027) UDI (01)00887868038938 (17)270613 (10)858830; 858930 (06/13/2027) UDI (01)00887868038938 (17)270613 (10)858930 | 638 units |
| Z-0484-2018 | Affixus Hip Fracture Nail, RH 130 DEG 9MM X 440MM; Item No. 814509440; Lot No. (Exp. Date) UDI: 438020 (05/18/2027) UDI (01)00887868038945 (17)270518 (10)438020 | 638 units |
What to do — step by step
Check Product Details
Verify the item number (814311180) and lot number (459190) on the product packaging.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “US nationwide distribution. Also Portugal and the Netherlands.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 20 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.
Questions people ask
Is there a risk of serious injury from this product?
The recall indicates a potential assembly issue that could lead to improper fixation, but the official notice does not describe a risk of serious injury.
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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-0420-2018 (August 7, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0420-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 18, 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.