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FDAFebruary 14, 2022device

BIOMET TRAUMA A.L.P.S. FIBULA COMPOSITE LOCKING PLATE 8 HOLE, Item # 856204008. Devices are packaged in a vacuum sealed nylon pouch, which is placed in a carton with the appropriate IFU and patient record labels. Identifying labels on the pouch and the carton.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgical intervention, and/or extension of surgery to find another part.

What to do

FDA enforcement status: Terminated

Brands named

biomet

UPCs

00887868445897

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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BIOMET TRAUMA A.L.P.S. FIBULA COMPOSITE LOCKING PLATE 8 HOLE, Item # 856204008. Devices are packaged in a vacuum sealed nylon pouch, which is placed in a carton with the appropriate IFU and patient record labels. Identifying labels on the pouch and the carton. — Recall Details · AllClear