Biomet, Inc. recalls Unilateral external fixation ankle clamp Product Usage: Unilateral external fixation for use treatment of bone conditio…

Recall date

May 1, 2015

Source

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

Recall number

Z-1741-2015

FDA classification

Class II

Brand / firm

Biomet, Inc.

Sold / distributed

US Nationwide Distribution in the states of CA, TX, FL, NC, MI, GA.

Why it was recalled

Ankle clamp was assembled incorrectly; the offset of the pin to the pivot point is reversed. This prevents complete range of motion and if pushed too far may loosen the pin from the bone. A revision surgery may be necessary to adequately reconnect the fixator to the bone.

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

What was recalled

Unilateral external fixation ankle clamp Product Usage: Unilateral external fixation for use treatment of bone conditions amenable to treatment by use of external fixation modality