Zimmer Biomet recalls Alvarado Knee Holder Base Plate Assembly and Foot Pieces due to potential foreign material from inadequate cleaning. Affected items have specific item numbers and were sold with all lot codes.
Foreign Material in the Alvarado Knee Holder Base Plate Assembly and Foot Piece and Alvarado II Base Plate and Foot Piece due to potentially inadequate cleaning procedures
Zimmer Biomet is recalling certain knee surgery holders because foreign material might be present due to cleaning issues. This could cause problems during surgery if not properly cleaned.
Foreign material in the knee holder components could potentially cause issues during surgery if not properly cleaned. The hazard comes from inadequate cleaning procedures that might leave foreign particles in the device.
Surgical teams using Zimmer Biomet Alvarado Knee Holder Base Plate Assembly and Foot Pieces for knee surgery are affected. Patients undergoing knee surgery with these devices are at risk if foreign material causes complications.
Check for item numbers: 00-1320-010-00 (Foot Piece), 00-1320-011-00 (Base Plate Assembly), 00-1320-210-00 (Alvarado II Foot Piece), or 00-1320-211-00 (Alvarado II Base Plate). All lot codes are affected.
Look for specific item numbers on the device: 00-1320-010-00, 00-1320-011-00, 00-1320-210-00, or 00-1320-211-00.
Foreign material might be present due to inadequate cleaning procedures, which could cause issues during surgery.
Item numbers 00-1320-010-00 (Foot Piece), 00-1320-011-00 (Base Plate Assembly), 00-1320-210-00 (Alvarado II Foot Piece), and 00-1320-211-00 (Alvarado II Base Plate).
No specific stop-use instruction is given; the recall focuses on checking item numbers and potential cleaning issues.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1494-2019 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-1494-2019 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.
