Zimmer Biomet recalls Affixus Hip Fracture Nails with open sterile packaging during surgery. Affected lot numbers: 436160. 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 hip fracture nails that were found to have open sterile packaging during surgery. This could lead to infection risks if the product was used without proper sterility.
The sterile packaging was found to be open before surgery, which could allow bacteria to enter the surgical site. This increases the risk of infection during the procedure.
Surgical teams using the Affixus Hip Fracture Nail Right 125 model with lot number 436160 are affected. Patients undergoing hip fracture surgery are at risk of infection if the product was used without proper sterility.
Check for the Affixus Hip Fracture Nail Right 125 model with item number 814309380 and lot number 436160. The product is intended for hip fracture fixation.
Look for the lot number 436160 on the packaging to determine if your item is affected.
The recall indicates the sterile packaging was open during surgery, which could lead to infection risks. The product is not safe for use as recalled.
The recall notice does not specify a remedy, so no action is required beyond checking the lot number.
Check for the lot number 436160 on the packaging of the Affixus Hip Fracture Nail Right 125 model with item number 814309380.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0128-2019 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0128-2019 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.
