Zimmer Biomet recalls Vanguard Knee System -PS Open Box Femoral Left 62.5mm (Item 183126) due to mismatched labels between outer carton and inner sterile packaging.
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 incorrect surgical use if the wrong implant is used during surgery.
The labels on the outer carton or patient labels do not match the labels on the inner sterile packaging. This mismatch could cause confusion during surgery if the wrong implant is used, potentially leading to incorrect surgical procedures.
Patients who received this specific knee implant (Vanguard Knee System -PS Open Box Femoral Left, 62.5 mm, Item Number 183126) are affected. Surgeons and medical facilities using this model during procedures are at risk.
Check for the product name 'Vanguard Knee System -PS Open Box Femoral Left', size 62.5 mm, and item number 183126. The lot number is J6255863 and UDI code is (01)00880304270794(17)280411(10)J6265594.
Verify that the labels on the outer carton and patient labels match the inner sterile packaging labels.
The recall is for label mismatch between outer packaging and inner sterile packaging, which could lead to incorrect surgical use but does not pose an immediate risk of injury.
Look for the product name 'Vanguard Knee System -PS Open Box Femoral Left', size 62.5 mm, and item number 183126 with lot number J6255863 and UDI code (01)00880304270794(17)280411(10)J6265594.
No action is required for the product itself, but you should check the labels to ensure they match before use.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0495-2019 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0495-2019 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.
