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Biomet, Inc. Recall: Unilateral external fixation ankle clamp Product Usage: Unilateral ex

Biomet, Inc. Recall: Unilateral external fixation ankle clamp Product Usage: Unilateral ex is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Biomet, Inc.; Product: Unilateral external fixation ankle clamp Product Usage: Unilateral external fixation for use treatment of bone conditions am

Recalling firmBiomet, Inc.
ProductUnilateral external fixation ankle clamp Product Usage: Unilateral external fixation for use treatment of bone conditions amenable to treatment by use of external fixation modality
Reason for recallAnkle 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.
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusTerminated
DistributionUS Nationwide Distribution in the states of CA, TX, FL, NC, MI, GA.
Recall initiated20150501
Recall numberZ-1741-2015
Categorydevice
StateIN
CountryUnited States

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