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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Zimmer Biomet, Inc.: There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Agency Publication Date: October 18, 2018
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Affected Products

Product: Affixus 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 287770

Lot Numbers:
Numbers
Product: Affixus Hip Fracture Nail Right 125 9 mm x 260 mm, Item Number 814309260 Product Usage: Intended for the fixation of fractures

Lot Numbers: 450640

Lot Numbers:
Numbers
Product: Affixus 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 450750

Lot Numbers:
Numbers
Product: Affixus Hip Fracture Nail Right 125 9 mm x 320 mm, Item Number 814309320 Product Usage: Intended for the fixation of fractures

Lot Numbers: 450770 450790

Lot Numbers:
Numbers
Product: Affixus 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 616470

Lot Numbers:
Numbers
Product: Affixus Hip Fracture Nail Right 125 9 mm x 360 mm, Item Number 814309360 Product Usage: Intended for the fixation of fractures

Lot Numbers: 219760

Lot Numbers:
Numbers
Product: Affixus Hip Fracture Nail Right 125 9 mm x 380 mm, Item Number 814309380 Product Usage: Intended for the fixation of fractures

Lot Numbers: 436160

Lot Numbers:
Numbers
Product: Affixus Hip Fracture Nail Right 125 9 mm x 440 mm, Item Number 814309440 Product Usage: Intended for the fixation of fractures

Lot Numbers: 289130

Lot Numbers:
Numbers
Product: Affixus Hip Fracture Nail Right 125 9 mm x 460 mm, Item Number 814311460 Product Usage: Intended for the fixation of fractures

Lot Numbers: 369120

Lot Numbers:
Numbers
Product: Affixus 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 287740

Lot Numbers:
Numbers
Product: Affixus Hip Fracture Nail Right 125 11 mm x 340 mm, Item Number 814311340 Product Usage: Intended for the fixation of fractures

Lot Numbers: 244090 288670

Lot Numbers:
Numbers
Product: Affixus Hip Fracture Nail Right 125 11 mm x 360 mm, Item Number 814311360 Product Usage: Intended for the fixation of fractures

Lot Numbers: 244170

Lot Numbers:
Numbers
Product: Affixus Hip Fracture Nail Right 125 11 mm x 380 mm, Item Number 814311380 Product Usage: Intended for the fixation of fractures

Lot Numbers: 244180

Lot Numbers:
Numbers
Product: Affixus 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 369260

Lot Numbers:
Numbers
Product: Affixus Hip Fracture Nail Right 125 11 mm x 440 mm, Item Number 814311440 Product Usage: Intended for the fixation of fractures

Lot Numbers: 369280

Lot Numbers:
Numbers
Product: Affixus Hip Fracture Nail Right 125 11 mm x 460 mm, Item Number 814311460 Product Usage: Intended for the fixation of fractures

Lot Numbers: 436200

Lot Numbers:
Numbers
Product: Affixus Hip Fracture Nail Right 125 13 mm x 180 mm, Item Number 814313180 Product Usage: Intended for the fixation of fractures

Lot Numbers: 244220 558020

Lot Numbers:
Numbers
Product: Affixus Hip Fracture Nail Right 125 13 mm x 260 mm, Item Number 814313260 Product Usage: Intended for the fixation of fractures

Lot Numbers: 343500

Lot Numbers:
Numbers
Product: Affixus Hip Fracture Nail Right 125 13 mm x 280 mm, Item Number 814313280 Product Usage: Intended for the fixation of fractures

Lot Numbers: 369340

Lot Numbers:
Numbers
Product: Affixus Hip Fracture Nail Right 125 13 mm x 300 mm, Item Number 814313300 Product Usage: Intended for the fixation of fractures

Lot Numbers: 616680 616780

Lot Numbers:
Numbers
Product: Affixus Hip Fracture Nail Right 125 13 mm x 360 mm, Item Number 814313360 Product Usage: Intended for the fixation of fractures

Lot Numbers: 136750

Lot Numbers:
Numbers
Product: Affixus Hip Fracture Nail Right 125 13 mm x 400 mm, Item Number 814313400 Product Usage: Intended for the fixation of fractures

Lot Numbers: 584890

Lot Numbers:
Numbers
Product: Affixus Hip Fracture Nail Right 125 13 mm x 440 mm, Item Number 814313440 Product Usage: Intended for the fixation of fractures

Lot Numbers: 678960 678970

Lot Numbers:
Numbers
Product: Affixus Hip Fracture Nail Left 125 9 mm x 260 mm, Item Number 814409260 Product Usage: Intended for the fixation of fractures

Lot Numbers: 679000

Lot Numbers:
Numbers
Product: Affixus 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 679050

Lot Numbers:
Numbers
Product: Affixus Hip Fracture Nail Left 125 9 mm x 320 mm, Item Number 814409320 Product Usage: Intended for the fixation of fractures

Lot Numbers:558060

Lot Numbers:
Numbers
Product: Affixus Hip Fracture Nail Left 125 9 mm x 440 mm, Item Number 814409440 Product Usage: Intended for the fixation of fractures

Lot Numbers: 584790 584810

Lot Numbers:
Numbers
Product: Affixus Hip Fracture Nail Left 125 9 mm x 460 mm, Item Number 814409460 Product Usage: Intended for the fixation of fractures

Lot Numbers: 584760 584770

Lot Numbers:
Numbers
Product: Affixus Hip Fracture Nail Left 125 11 mm x 260 mm, Item Number 814411260 Product Usage: Intended for the fixation of fractures

Lot Numbers: 244270 679300

Lot Numbers:
Numbers
Product: Affixus Hip Fracture Nail Left 125 11 mm x 320 mm, Item Number 814411320 Product Usage: Intended for the fixation of fractures

Lot Numbers: 679160

Lot Numbers:
Numbers
Product: Affixus Hip Fracture Nail - Left 125 11mm x 340mm, Item Number 814411340 Product Usage: Intended for the fixation of fractures

Lot Numbers: 244280 558120 558130

Lot Numbers:
Numbers
Product: Affixus 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 343550

Lot Numbers:
Numbers
Product: Affixus Hip Fracture Nail Left 125 13 mm x 260 mm, Item Number 814413260 Product Usage: Intended for the fixation of fractures

Lot Numbers: 679240

Lot Numbers:
Numbers
Product: Affixus Hip Fracture Nail Left 125 13 mm x 340 mm, Item Number 814413340 Product Usage: Intended for the fixation of fractures

Lot Numbers: 369380 436290

Lot Numbers:
Numbers
Product: Affixus Hip Fracture Nail Left 125 13 mm x 360 mm, Item Number 814413360 Product Usage: Intended for the fixation of fractures

Lot Numbers: 369400 369410

Lot Numbers:
Numbers
Product: Affixus Hip Fracture Nail Right 130 9 mm x 320 mm, Item Number 814509320 Product Usage: Intended for the fixation of fractures

Lot Numbers: 201440

Lot Numbers:
Numbers
Product: Affixus 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 436430

Lot Numbers:
Numbers
Product: Affixus Hip Fracture Nail Right 130 11 mm x 320 mm, Item Number 814511320 Product Usage: Intended for the fixation of fractures

Lot Numbers: 616240 616250

Lot Numbers:
Numbers
Product: Affixus Hip Fracture Nail Right 130 11 mm x 340 mm, Item Number 814511340 Product Usage: Intended for the fixation of fractures

Lot Numbers: 369640

Lot Numbers:
Numbers
Product: Affixus Hip Fracture Nail Right 130 11 mm x 360 mm, Item Number 814511360 Product Usage: Intended for the fixation of fractures

Lot Numbers: 343590 343610

Lot Numbers:
Numbers
Product: Affixus Hip Fracture Nail Right 130 11 mm x 400 mm, Item Number 814511400 Product Usage: Intended for the fixation of fractures

Lot Numbers: 343630

Lot Numbers:
Numbers
Product: Affixus 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 616640

Lot Numbers:
Numbers
Product: Affixus Hip Fracture Nail Left 130 9 mm x 360 mm, Item Number 814609360 Product Usage: Intended for the fixation of fractures

Lot Numbers: 616460

Lot Numbers:
Numbers
Product: Affixus Hip Fracture Nail Left 130 11 mm x 360 mm, Item Number 814611360 Product Usage: Intended for the fixation of fractures

Lot Numbers: 289190

Lot Numbers:
Numbers
Product: Affixus Hip Fracture Nail Left 130 11 mm x 380 mm, Item Number 814611380 Product Usage: Intended for the fixation of fractures

Lot Numbers: 287810 343660

Lot Numbers:
Numbers
Product: Affixus Hip Fracture Nail Left 130 11 mm x 400 mm, Item Number 814611400 Product Usage: Intended for the fixation of fractures

Lot Numbers: 500220

Lot Numbers:
Numbers
Product: Affixus Hip Fracture Nail Left 130 15 mm x 360 mm, Item Number 814615360 Product Usage: Intended for the fixation of fractures

Lot Numbers: 436650

Lot Numbers:
Numbers
Product: Affixus Hip Fracture Nail 125 9 mm x 165 mm, Item Number 816709165 Product Usage: Intended for the fixation of fractures

Lot Numbers: 694950

Lot Numbers:
Numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81038
Status: Resolved
Manufacturer: Zimmer Biomet, Inc.
Manufactured In: United States
Units Affected: 48 products (153; 24; 72; 38; 51; 24; 19; 14; 20; 153; 27; 12; 20; 51; 20; 18; 34; 24; 22; 27; 9; 10; 25; 16; 78; 14; 29; 30; 33; 15; 60; 68; 16; 31; 32; 22; 85; 39; 24; 44; 20; 50; 19; 14; 41; 16; 10; 20)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.