Biomet recalls A.L.P.S. T15 Multi-Directional Locking Screws due to incomplete design history files. This may affect surgical implants used in fracture stabilization. No action is required as the product is not yet in use.
Distributed to the field without having completed design history files or design transfer activities
Biomet is recalling a specific type of surgical screw used in fracture repair because it was distributed without completing required design documentation. This recall does not pose an immediate risk to users since the product has not been used in actual surgeries.
The screws were distributed without completing necessary design history files or transfer activities. This could potentially lead to regulatory or safety issues if the product is used in actual surgical procedures, but the recall indicates it has not been deployed.
Surgical teams and hospitals that may have received this screw for fracture stabilization procedures. Patients are not at risk as the product has not been used in actual surgeries.
Check for the A.L.P.S. T15 Multi-Directional Locking Screw with item number 110017960. The lot number RM540H (01)00887868132490(17)260623(10)RM540H is associated with this recall.
Verify the item number 110017960 and lot number RM540H (01)00887868132490(17)260623(10)RM540H on the screw packaging.
The recall states the screws were distributed without completed design history files, but the product has not been used in actual surgeries, so no immediate risk exists.
No action is required as the product has not been deployed in surgeries. The recall is for potential future use, not current products.
Check for the item number 110017960 and lot number RM540H (01)00887868132490(17)260623(10)RM540H on the screw packaging.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-2310-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-2310-2020 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.
