Zimmer Biomet recalls Affixus Hip Fracture Nails with open sterile packaging during surgery. Affected lot numbers: 558060. 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 sterilization.
The sterile packaging was found open during surgery, meaning the product could have been contaminated before use. This increases the risk of infection for patients who receive the nail without proper sterilization.
Surgical teams using the Affixus Hip Fracture Nail Left 125 (9 mm x 320 mm) with lot number 558060 are affected. Patients undergoing hip fracture surgery are at risk of infection if the product was used without proper sterilization.
Check for the product name 'Affixus Hip Fracture Nail Left 125' with dimensions 9 mm x 320 mm. The affected lot number is 558060. This product was sold for surgical use.
Look for the lot number 558060 on the packaging to confirm if the product is affected.
The recall notice does not specify any remedy or fix for this issue.
Check for the product name 'Affixus Hip Fracture Nail Left 125' with dimensions 9 mm x 320 mm and lot number 558060.
The recall notice does not specify any action steps for affected products.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0147-2019 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0147-2019 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.