Biomet recalls 3.2mm drill block guide sleeve for proximal humerus plating system due to incomplete design history files. This may affect surgical implants used in fracture stabilization.
Distributed to the field without having completed design history files or design transfer activities
Biomet is recalling a specific 3.2mm drill block guide sleeve for proximal humerus plating systems because it was distributed without completing required design history files. This could mean the product isn't safe for surgical use as intended.
The product was distributed without completing necessary design history files. This means the device may not meet safety standards for surgical use, potentially causing complications during fracture stabilization procedures.
Surgical patients who received this specific drill sleeve during procedures. Surgeons using the product for fracture stabilization are most at risk.
Check for the item number 110017553 on the product. The specific lot number 3286A (01)00887868135033(10)3286A was used in this recall. This product is for temporary internal fixation of fractures.
Look for item number 110017553 and lot number 3286A (01)00887868135033(10)3286A on the product.
The recall states the product was distributed without completing design history files, so it may not be safe for surgical use as intended.
The recall does not specify a remedy, so there is no action required beyond checking if you have the specific item number and lot number.
Check for item number 110017553 and lot number 3286A (01)00887868135033(10)3286A on the product.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-2306-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-2306-2020 from 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.
