Zimmer Biomet recalls ball tip guide wires (3.2mm x 55cm) due to potential sterile barrier breaches causing infection risk. Affected units may have packaging flaws leading to contamination during surgery.
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 ball tip guide wires that could have packaging flaws causing sterile barrier breaches during surgery. This poses a risk of infection for patients undergoing procedures requiring these wires.
The guide wires are packaged in a configuration that may not properly seal, potentially allowing contamination. This could lead to infection if the sterile barrier is breached during surgical procedures.
Surgical professionals and hospitals using Zimmer Biomet ball tip guide wires for implant procedures are likely affected. Patients undergoing surgery with these wires face the infection risk.
Check for model numbers 469055 or other listed numbers in the product description. The wires are intended for use as guide pins during surgical implant procedures.
Identify if your guide wire has model numbers listed in the product description (e.g., 46905: 410640, 410650, etc.)
The packaging may not seal properly, potentially leading to sterile barrier breaches during surgery and increasing infection risk.
Check for model numbers listed in the product description, such as 469055 or other numbers like 410640, 410650, etc.
The recall does not specify a stop-use instruction; affected units should be checked for model numbers and handled with caution.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-2233-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-2233-2018 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.
