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

Recall Z-2046-2015 — A.L.P.S. Foot Locking Calcaneus Plate,Small-Right. Provides the orthopaedic surgeon a means of bone fixation and helps generally in the management of fractures and reconstructive surgeries.

U.S. FDA — Device Enforcement · United States · 2015-06-04 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2046-2015
Date of alert
2015-06-04
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Biomet, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
816209001
Reported risk: The thread location on one of the thread holes is offset from the axis of the predrill hole. The threads are too deep on one side and too shallow on the other. The locking screw may back out of the plate if it does not achieve proper purchase. This may require a revision surgery to replace or remove the screw and/or plate. The threads, not uniformly loaded, may shear off, causing metal slivers.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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