Zimmer Biomet recalls Affixus Hip Fracture Nails with open sterile packaging during surgery. Affected lot numbers: 201440. 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 may have open sterile packaging during surgery. This could lead to infection or contamination if used without proper sterilization.
The sterile packaging was found open before surgery, which could allow contamination. This might lead to infection or improper healing if the nail is used without proper sterilization.
Patients who received the Affixus Hip Fracture Nail Right 130 (9 mm x 320 mm) with lot number 201440 during surgery. Surgeons and medical staff using the product are at risk of potential contamination.
Check for the product name 'Affixus Hip Fracture Nail Right 130' and lot number 201440. The item was sold for surgical use only.
Verify if the sterile packaging was open before surgery. If open, contact your surgeon immediately.
The recall indicates potential open packaging during surgery, which could lead to contamination. Do not use if packaging is open.
Contact your surgeon to check if the product was used with open packaging. No specific remedy is stated in the recall notice.
Look for the product name 'Affixus Hip Fracture Nail Right 130' and lot number 201440. The product was sold for surgical use only.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0157-2019 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0157-2019 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.