Zimmer Biomet recalls certain humeral guide wires due to potential sterility compromise from creases in the sealing area, affecting single-use surgical instruments sold before Sept 30, 2023.
Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
Zimmer Biomet is recalling specific humeral guide wires used in orthopedic surgery because creases in the sealing area could compromise sterility. This risk means the instruments might not be sterile when used, potentially causing infections during surgery.
Creases in the sealing area on the wire's end opposite the chevron opening can compromise the product's sterility. This means the instrument might not be sterile when used during surgery, increasing infection risk for patients.
Orthopedic surgeons and surgical teams using the recalled humeral guide wires for single-use procedures. Patients undergoing surgery with these instruments are at risk of infection if the wires were not properly sterile.
Check for the item number 47-2255-008-00 on the packaging. The product is a single-use surgical instrument for orthopedic procedures and was sold before September 30, 2023.
Look for the item number 47-2255-008-00 on the packaging or label.
The recall is due to creases in the sealing area that could compromise sterility, potentially leading to infections during surgery.
The product is not safe for use as the sterility risk could cause infections during surgery.
The official recall notice does not specify a remedy, so contact Zimmer Biomet directly for guidance.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0536-2019 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0536-2019 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.
