Zimmer Biomet recalls Affixus Hip Fracture Nails with open sterile packaging during surgery. Affected lot numbers: 436470, 616630, 616640. No remedy specified in recall notice.
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
Zimmer Biomet is recalling certain Affixus Hip Fracture Nails because the sterile packaging may be open when opened during surgery. This could lead to contamination and infection risks for patients. The recall affects specific lot numbers.
The sterile packaging may be open when the product is opened in surgery, which could lead to contamination. This contamination risk might cause infections in patients during the procedure.
Surgical teams using the affected lot numbers of Affixus Hip Fracture Nails during procedures. Patients receiving these implants face potential infection risks if the packaging was compromised.
Check the lot numbers on the packaging: 436470, 616630, or 616640. The product is an Affixus Hip Fracture Nail Right 130 with dimensions 13 mm x 360 mm.
Verify the lot number on the packaging to see if it is one of 436470, 616630, or 616640.
The recall is due to complaints that the sterile packaging may be open when the product is opened during surgery, which could lead to contamination.
The recall notice does not specify a remedy, so check the lot numbers and contact Zimmer Biomet for further instructions.
The recall indicates a potential contamination risk, but the notice does not specify if this leads to serious injury or death.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0163-2019 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0163-2019 from Zimmer Biomet. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
