Zimmer Biomet recalls Vanguard Knee System -PS Open Box Femoral Right, 65 mm (Item 183:108) due to mismatched labels between outer carton and inner sterile packaging. This could lead to incorrect surgical implant use.
Label on the outer carton or the patient labels does not match label on the inner sterile packaging
Zimmer Biomet is recalling a specific knee implant model because the labels on the outer packaging don't match the inner sterile packaging. This mismatch could lead to using the wrong implant during surgery, which is dangerous.
The outer carton or patient labels do not match the inner sterile packaging. This mismatch could lead to using the wrong implant during surgery, which is dangerous because surgical implants must be precisely matched to the patient's anatomy.
Orthopedic surgeons and hospitals that purchased the Vanguard Knee System -PS Open Box Femoral Right, 65 mm (Item Number 183108) are affected. Patients receiving this implant are at risk if the label mismatch causes incorrect implant use.
Check for the product name 'Vanguard Knee System -PS Open Box Femoral Right, 65 mm' with Item Number 183108. The lot number J6265594 and UDI code (01)00880304270893(17)280411(10)J6255863 are also associated with this recall.
Verify that the outer carton or patient labels match the inner sterile packaging labels. If they don't match, stop using the implant.
The recall is happening because the labels on the outer carton or patient labels do not match the inner sterile packaging, which could lead to using the wrong implant during surgery.
If you have the Vanguard Knee System -PS Open Box Femoral Right, 65 mm (Item Number 183108), check that the outer carton and inner packaging labels match. If they don't, stop using it and contact Zimmer Biomet.
The official recall does not provide a fix; the remedy is not stated in the record.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0496-2019 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0496-2019 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.
