Biomet recalls A.L.P.S. T15 cortical screws due to incomplete design history files. This affects temporary fracture fixation devices sold for medical use. Consumers should contact Biomet for details.
Distributed to the field without having completed design history files or design transfer activities
Biomet is recalling A.L.P.S. T15 low-profile cortical screws used for temporary fracture fixation. The recall is because these screws were distributed without completing required design history files, which could affect medical safety.
The screws were distributed without completing necessary design history files. This means the medical device might not meet safety standards for temporary fracture fixation, potentially leading to complications during healing.
Medical professionals who used these screws for temporary fracture stabilization are likely affected. Patients receiving the screws during surgery are at risk if the design history files were incomplete.
Check for the product name 'A.L.P.S. T15 LOW PROFILE CORTICAL SCREW 3.5mm x 28mm' with item number 110017628. These screws were used for temporary internal fixation of fractures during surgery.
Reach out to Biomet directly for specific instructions on handling the recalled screws.
The screws were distributed without completing required design history files, which could affect medical safety.
The recall does not specify a stop-use instruction, so you should contact Biomet for guidance.
Look for the product name 'A.L.P.S. T15 LOW PROFILE CORTICAL SCREW 3.5mm x 28mm' with item number 110017628.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-2308-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-2308-2020 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.
