Zimmer Biomet recalls specific PLGA screws due to commingled models causing potential misuse in surgical procedures. Affected items have unique identifiers; contact for replacement.
The Gentle Thread PLGA Round Head, 7x20mm and the Gentle Thread PLGA Full Thread 10x30 have been commingled.
Zimmer Biomet is recalling certain PLGA round head interference screws because they have been mixed with other models. This could lead to incorrect surgical use if the wrong screw is used during procedures.
The screws have been commingled, meaning they are mixed with other models. This could lead to using the wrong screw size during surgery, potentially causing complications.
Surgical professionals and hospitals using the specific screw models are most at risk. Patients receiving these screws during surgery may be affected if the wrong model is used.
Check for the item number 905612 and lot number 611330 on the screw packaging. The unique identifier (UDI) starts with (1)00880304008526(17)221010(10)611330.
Look for item number 905612 and lot number 611330 on the screw packaging.
The screws have been commingled with other models, which could lead to using the wrong size during surgery.
Check for item number 905612 and lot number 611330 on the packaging. The unique identifier starts with (1)00880304008526(17)221010(10)611330.
The recall 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-3176-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-3176-2018 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.