Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2308-2020 — A.L.P.S. T15 LOW PROFILE CORTICAL SCREW 3.5mm x 28mm, Item Number: 110017628 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.

U.S. FDA — Device Enforcement · United States · 2020-05-14 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2308-2020
Date of alert: 2020-05-14
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Biomet
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00887868131769

Reported risk: Distributed to the field without having completed design history files or design transfer activities

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-2308-2020 — A.L.P.S. T15 LOW PROFILE CORTICAL SCREW 3.5mm x 28mm, Item Number: 110017628 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.

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