Zimmer Biomet recalls Vanguard 360 Revision Knee System 63x 10mm Universal Tibial Block Augment Model 185221 due to one bolt missing in sterile package. This could lead to improper implant fixation.
The implant only has one bolt in the sterile package but it should have had two.
Zimmer Biomet is recalling a specific knee implant model because the sterile package contains only one bolt instead of two. This could cause improper implant fixation and potential complications.
The implant's sterile package has only one bolt, but it should have two. This could lead to improper fixation of the implant during surgery, potentially causing instability or complications.
Patients who received this specific knee implant model during surgery are affected. Those with the model number 185221 are most at risk.
Check if your implant has model number 185221. This product was used in total knee arthroplasty procedures and sold with lot number 320390.
Verify your implant model number is 185221 to determine if it is affected.
The recall states the sterile package has only one bolt instead of two, which could lead to improper implant fixation. However, the hazard is not described as causing serious injury in normal use.
The recall does not specify a remedy, so contact Zimmer Biomet directly for guidance.
Look for model number 185221 on your implant. This product was used in total knee arthroplasty procedures and sold with lot number 320390.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-3249-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-3249-2018 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.