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Lower risk Medical device recall · FDA · Published August 8, 2018

Zimmer Biomet Affixus Hip Nail Recall: Sterile Packaging Opens During Surgery

Zimmer Biomet recalls Affixus Hip Fracture Nails with lot number 369640 due to sterile packaging opening during surgery. Affected patients should contact the company for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0160-2019Medical deviceZimmer Biomet ›
Take action

Contact the company

Recalling firmZimmer Biomet, Inc.56 E Bell Dr · Warsaw, IN 46582-6989
✎ GovInfoNow plain-language explainer

Zimmer Biomet is recalling hip fracture nails that may have sterile packaging that opens during surgery. This could lead to contamination of the surgical site and infection risks for patients. Read more at govinfonow.com/recall/70085-zimmer-biomet-affixus-hip-nail-recall-sterile-packaging-opens-during.

Source Summary by GovInfoNow · govinfonow.com/recall/70085-zimmer-biomet-affixus-hip-nail-recall-sterile-packaging-opens-during · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0160-2019

Cite this page

“Zimmer Biomet Affixus Hip Nail Recall: Sterile Packaging Opens During Surgery.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/70085-zimmer-biomet-affixus-hip-nail-recall-sterile-packaging-opens-during. Based on FDA recall #Z-0160-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0160-2019%22&limit=1).

The FDA announced on 2018-08-08 that Zimmer Biomet, Inc. voluntarily recalled Affixus Hip Fracture Nail Right 130 11 mm x 340 mm due to sterile packaging being open upon surgical use. The agency classified the recall as Class II.

How to tell if you have it

  • Brand: Zimmer Biomet
  • Product: Affixus Hip Fracture Nail Right 130 11 mm x 340 mm
  • Item Number: 814511340
  • Lot Numbers: 369640

The hazard

According to the FDA, complaints indicated that when the product was opened in surgery, the sterile packaging was already open.

Context

GovInfoNow's records show Zimmer Biomet, Inc. has 94 other recalls on record since 2017-06-05. Other recent recalls of similar products include Zimmer Affixus Antegrade Femoral Nails Recall: Risk of Fracture (2025-12-02), Biomet Intramedullary Bone Saw Blade Recall: Sterile Packaging Risk (2026-07-01), and Zimmer Affixus Femoral Nails Recall: Risk of Fracture from Undersized Diameter (2025-12-02).

How to tell if you have this one

Check for the product name 'Affixus Hip Fracture Nail Right 130' and lot number 369640 on the packaging. The item was sold for surgical use.

  • Brand
    Zimmer Biomet
  • Category
    Medical device
FDA recall event · 48 products

All 48 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
    Worldwide Distribution - US Nationwide in the states of: AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WY. The products were distributed to the following foreign countries: Chile, Netherlands.
Recall numberProduct, codes & lotsQuantity
Z-0122-2019Affixus Hip Fracture Nail 125 9 mm x 180 mm, Item Number 814309180 Product Usage: Intended for the fixation of fractures; Lot Numbers: 177820 177830 177890 177910 177920 244120 287770153
Z-0123-2019Affixus Hip Fracture Nail Right 125 9 mm x 260 mm, Item Number 814309260 Product Usage: Intended for the fixation of fractures; Lot Numbers: 45064024
Z-0124-2019Affixus Hip Fracture Nail Right 125 9 mm x 300 mm, Item Number 814309300 Product Usage: Intended for the fixation of fractures; Lot Numbers: 219750 244110 45075072
Z-0125-2019Affixus Hip Fracture Nail Right 125 9 mm x 320 mm, Item Number 814309320 Product Usage: Intended for the fixation of fractures; Lot Numbers: 450770 45079038
Z-0126-2019Affixus Hip Fracture Nail Right 125 9 mm x 340 mm, Item Number 814309340 Product Usage: Intended for the fixation of fractures; Lot Numbers: 244100 584910 61647051
Z-0127-2019Affixus Hip Fracture Nail Right 125 9 mm x 360 mm, Item Number 814309360 Product Usage: Intended for the fixation of fractures; Lot Numbers: 21976024
Z-0128-2019Affixus Hip Fracture Nail Right 125 9 mm x 380 mm, Item Number 814309380 Product Usage: Intended for the fixation of fractures; Lot Numbers: 43616019
Z-0129-2019Affixus Hip Fracture Nail Right 125 9 mm x 440 mm, Item Number 814309440 Product Usage: Intended for the fixation of fractures; Lot Numbers: 28913014
Z-0130-2019Affixus Hip Fracture Nail Right 125 9 mm x 460 mm, Item Number 814311460 Product Usage: Intended for the fixation of fractures; Lot Numbers: 36912020
Z-0131-2019Affixus Hip Fracture Nail 125 11mm x 180mm, Item Number 814311180 Product Usage: Intended for the fixation of fractures; Lot Numbers: 129900 129910 178050 178060 178070 287720 287740153
Z-0132-2019Affixus Hip Fracture Nail Right 125 11 mm x 340 mm, Item Number 814311340 Product Usage: Intended for the fixation of fractures; Lot Numbers: 244090 28867027
Z-0133-2019Affixus Hip Fracture Nail Right 125 11 mm x 360 mm, Item Number 814311360 Product Usage: Intended for the fixation of fractures; Lot Numbers: 24417012
Z-0134-2019Affixus Hip Fracture Nail Right 125 11 mm x 380 mm, Item Number 814311380 Product Usage: Intended for the fixation of fractures; Lot Numbers: 24418020
Z-0135-2019Affixus Hip Fracture Nail Right 125 11 mm x 420 mm, Item Number 814311420 Product Usage: Intended for the fixation of fractures; Lot Numbers: 289160 369250 36926051
Z-0136-2019Affixus Hip Fracture Nail Right 125 11 mm x 440 mm, Item Number 814311440 Product Usage: Intended for the fixation of fractures; Lot Numbers: 36928020
Z-0137-2019Affixus Hip Fracture Nail Right 125 11 mm x 460 mm, Item Number 814311460 Product Usage: Intended for the fixation of fractures; Lot Numbers: 43620018
Z-0138-2019Affixus Hip Fracture Nail Right 125 13 mm x 180 mm, Item Number 814313180 Product Usage: Intended for the fixation of fractures; Lot Numbers: 244220 55802034
Z-0139-2019Affixus Hip Fracture Nail Right 125 13 mm x 260 mm, Item Number 814313260 Product Usage: Intended for the fixation of fractures; Lot Numbers: 34350024
Z-0140-2019Affixus Hip Fracture Nail Right 125 13 mm x 280 mm, Item Number 814313280 Product Usage: Intended for the fixation of fractures; Lot Numbers: 36934022
Z-0141-2019Affixus Hip Fracture Nail Right 125 13 mm x 300 mm, Item Number 814313300 Product Usage: Intended for the fixation of fractures; Lot Numbers: 616680 61678027
Z-0142-2019Affixus Hip Fracture Nail Right 125 13 mm x 360 mm, Item Number 814313360 Product Usage: Intended for the fixation of fractures; Lot Numbers: 1367509
Z-0143-2019Affixus Hip Fracture Nail Right 125 13 mm x 400 mm, Item Number 814313400 Product Usage: Intended for the fixation of fractures; Lot Numbers: 58489010
Z-0144-2019Affixus Hip Fracture Nail Right 125 13 mm x 440 mm, Item Number 814313440 Product Usage: Intended for the fixation of fractures; Lot Numbers: 678960 67897025
Z-0145-2019Affixus Hip Fracture Nail Left 125 9 mm x 260 mm, Item Number 814409260 Product Usage: Intended for the fixation of fractures; Lot Numbers: 67900016
Z-0146-2019Affixus Hip Fracture Nail Left 125 9 mm x 300 mm, Item Number 814409300 Product Usage: Intended for the fixation of fractures; Lot Numbers: 201230 201240 500030 67905078
Z-0147-2019Affixus Hip Fracture Nail Left 125 9 mm x 320 mm, Item Number 814409320 Product Usage: Intended for the fixation of fractures; Lot Numbers:55806014
Z-0148-2019Affixus Hip Fracture Nail Left 125 9 mm x 440 mm, Item Number 814409440 Product Usage: Intended for the fixation of fractures; Lot Numbers: 584790 58481029
Z-0149-2019Affixus Hip Fracture Nail Left 125 9 mm x 460 mm, Item Number 814409460 Product Usage: Intended for the fixation of fractures; Lot Numbers: 584760 58477030
Z-0150-2019Affixus Hip Fracture Nail Left 125 11 mm x 260 mm, Item Number 814411260 Product Usage: Intended for the fixation of fractures; Lot Numbers: 244270 67930033
Z-0151-2019Affixus Hip Fracture Nail Left 125 11 mm x 320 mm, Item Number 814411320 Product Usage: Intended for the fixation of fractures; Lot Numbers: 67916015
Z-0152-2019Affixus Hip Fracture Nail - Left 125 11mm x 340mm, Item Number 814411340 Product Usage: Intended for the fixation of fractures; Lot Numbers: 244280 558120 55813060
Z-0153-2019Affixus Hip Fracture Nail Left 125 11 mm x 360 mm, Item Number 814411360 Product Usage: Intended for the fixation of fractures; Lot Numbers: 244290 343530 34355068
Z-0154-2019Affixus Hip Fracture Nail Left 125 13 mm x 260 mm, Item Number 814413260 Product Usage: Intended for the fixation of fractures; Lot Numbers: 67924016
Z-0155-2019Affixus Hip Fracture Nail Left 125 13 mm x 340 mm, Item Number 814413340 Product Usage: Intended for the fixation of fractures; Lot Numbers: 369380 43629031
Z-0156-2019Affixus Hip Fracture Nail Left 125 13 mm x 360 mm, Item Number 814413360 Product Usage: Intended for the fixation of fractures; Lot Numbers: 369400 36941032
Z-0157-2019Affixus Hip Fracture Nail Right 130 9 mm x 320 mm, Item Number 814509320 Product Usage: Intended for the fixation of fractures; Lot Numbers: 20144022
Z-0158-2019Affixus Hip Fracture Nail 130 11 mm x 180 mm, Item Number 814511180 Product Usage: Intended for the fixation of fractures; Lot Numbers: 136520 244300 244320 43643085
Z-0159-2019Affixus Hip Fracture Nail Right 130 11 mm x 320 mm, Item Number 814511320 Product Usage: Intended for the fixation of fractures; Lot Numbers: 616240 61625039
Z-0160-2019Affixus Hip Fracture Nail Right 130 11 mm x 340 mm, Item Number 814511340 Product Usage: Intended for the fixation of fractures; Lot Numbers: 36964024
Z-0161-2019Affixus Hip Fracture Nail Right 130 11 mm x 360 mm, Item Number 814511360 Product Usage: Intended for the fixation of fractures; Lot Numbers: 343590 34361044
Z-0162-2019Affixus Hip Fracture Nail Right 130 11 mm x 400 mm, Item Number 814511400 Product Usage: Intended for the fixation of fractures; Lot Numbers: 34363020
Z-0163-2019Affixus Hip Fracture Nail Right 130 13 mm x 360 mm, Item Number 814513360 Product Usage: Intended for the fixation of fractures; Lot Numbers: 436470 616630 61664050
Z-0164-2019Affixus Hip Fracture Nail Left 130 9 mm x 360 mm, Item Number 814609360 Product Usage: Intended for the fixation of fractures; Lot Numbers: 61646019
Z-0165-2019Affixus Hip Fracture Nail Left 130 11 mm x 360 mm, Item Number 814611360 Product Usage: Intended for the fixation of fractures; Lot Numbers: 28919014
Z-0166-2019Affixus Hip Fracture Nail Left 130 11 mm x 380 mm, Item Number 814611380 Product Usage: Intended for the fixation of fractures; Lot Numbers: 287810 34366041
Z-0167-2019Affixus Hip Fracture Nail Left 130 11 mm x 400 mm, Item Number 814611400 Product Usage: Intended for the fixation of fractures; Lot Numbers: 50022016
Z-0168-2019Affixus Hip Fracture Nail Left 130 15 mm x 360 mm, Item Number 814615360 Product Usage: Intended for the fixation of fractures; Lot Numbers: 43665010
Z-0169-2019Affixus Hip Fracture Nail 125 9 mm x 165 mm, Item Number 816709165 Product Usage: Intended for the fixation of fractures; Lot Numbers: 69495020
Based on the official FDA remedy

What to do — step by step

  1. Contact Manufacturer

    Reach out to Zimmer Biomet directly for specific instructions on handling the recalled product.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 41 states.

Alaska: named in the noticeAKMaine: named in the noticeMEVermont: nationwideVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: named in the noticeMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: named in the noticeWYSouth Dakota: nationwideSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: nationwideNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: nationwideMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “Worldwide Distribution - US Nationwide in the states of: AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WY. The products…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, Wyoming.

Recall timeline

FDA terminated this recall 2 years after the firm started it.

1. Firm started the recall: Aug 8, 201812. FDA classified it Class II: Oct 17, 201823. Published in FDA’s Enforcement Report: Oct 24, 201834. FDA terminated the recall: Jul 30, 2020420182020
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Keep exploring

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-0160-2019 (August 8, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0160-2019 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA