Biomet, Inc. recalls A.L.P.S. Foot Locking Calcaneus Plate,Small-Right. Provides the orthopaedic surgeon a means of bone fixation and helps…

Recall date

June 4, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2046-2015

FDA classification

Class II

Brand / firm

Biomet, Inc.

Sold / distributed

Distributed in the states of TX, MD, PA, NJ, NC, MA, AZ, GA, FL, and AR. and the countries of Costa Rica CP and The Netherlands.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.