Zimmer Biomet recalls specific RECON Drill guide pins due to potential sterile barrier failure causing infection risk. Affected units have packaging design flaws 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 RECON Drills (6mm x 439mm) because their packaging might fail sterility checks, increasing infection risk during surgery. This affects surgeons and medical teams using these tools for bone procedures.
The guide pins' packaging design has flaws that could lead to sterile barrier breaches. This might allow contaminants to enter the surgical site, potentially causing infections during procedures.
Surgeons and medical teams using the RECON Drill for bone procedures are most at risk. The recall applies to specific model numbers sold in the U.S. during the product's lifetime.
Check for model numbers 001360, 008170, 106320, 330040, 952200, 924770, 446470, 446480, 337720, 032750, 971520, 957780, 295550 on the packaging. These drills are intended for bone procedures and were sold in the U.S. during the product's production period.
Look for model numbers on the packaging to confirm if the drill is affected.
The packaging design may fail sterility checks, leading to potential infection risk during surgery.
Model numbers 001360, 008170, 106320, 330040, 952200, 924770, 446470, 446480, 337720, 032750, 971520, 957780, 295550.
No action is required beyond checking the model numbers. The recall does not specify a stop-use instruction.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-2241-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-2241-2018 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.
