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Biomet, Inc. recalls Unilateral external fixation ankle clamp Product Usage: Unilateral external fixation for use treatment of bone condi
Recalled June 17, 2015 · FDA recall Z-1741-2015 · Biomet
Hazard
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. · FDA Class II
Units
19
Sold at
US Nationwide Distribution in the states of CA, TX, FL, NC, MI, GA.
Description
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.
Product
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
Manufacturer(s)
Biomet, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →