Zimmer Biomet recalls specific guide wires due to potential sterile barrier failure causing infection risk. Affected items have a packaging design flaw that may breach sterility during use.
The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging configuration have the potential for sterile barrier breach, leading to possible risk for infection.
Zimmer Biomet is recalling certain guide wires used in bone surgery because their packaging might fail sterility, increasing infection risk. Patients using these wires should stop using them immediately to prevent potential infection.
The guide wires have packaging that may fail sterility during use, potentially allowing bacteria to enter the surgical site. This could lead to infection if the sterile barrier is breached during implant insertion.
Surgical patients and medical professionals who use the recalled guide wires for bone procedures. Those with the specific model numbers listed in the recall are most at risk.
Check for model numbers 14-441053 or other specific codes listed in the recall notice. These guide wires are used for inserting implants into bones during surgery.
Discontinue use of the recalled guide wires to prevent potential infection from sterile barrier breaches.
The recall includes model numbers 14-441053 and other specific codes listed in the notice.
The packaging design may fail sterility during use, leading to potential infection risks.
Look for model numbers like 14-441053 or other codes listed in the recall notice.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-2242-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-2242-2018 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.