Zimmer Biomet recalls Vanguard Knee System PS Tibial Bearing (Part 183621) due to incorrect size labeling in the label master file, which could lead to improper knee joint replacement procedures.
The label master file was errantly set up as a 63/37mm instead of a 63/67mm. There is no 63/37 size offered, and the product is laser marked with the correct size.
Zimmer Biomet is recalling a specific knee implant component because its label incorrectly states a size that doesn't exist. This could cause improper fitting during surgery if the wrong size is used. The recall affects certain production lots.
The label master file for this implant part was set up with an incorrect size (63/37mm) instead of the correct size (63/67mm). Since the 63/37mm size is not available, the product is laser marked with the correct size. This labeling error could lead to using the wrong size during surgery, potentially causing improper implant fit.
Patients scheduled for knee joint replacement surgery using this specific implant part are affected. Surgeons and medical facilities that use this component in procedures are at risk.
Check for the part number 183621 on the implant. The product was sold with specific lot numbers: 120150, 140700, 173480, 205730, 294370, 338750, 421970, 516680, 678370, 700470, 722060, 775330, 858220, 888080, and 992290.
Look for the part number 183621 and the specific lot numbers listed in the recall notice.
The product is laser marked with the correct size, so it is safe for use if the correct size is confirmed by the surgeon.
Check for part number 183621 and the specific lot numbers: 120150, 140700, 173480, 205730, 294370, 338750, 421970, 516680, 678370, 700470, 722060, 775330, 858220, 888080, or 992290.
The recall does not require returning the product; it is safe to use if the correct size is confirmed by the surgeon.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-2183-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-2183-2018 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.
