FDAFDA · Food and drugs·Recall number Z-1741-2015
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
Published June 17, 2015 · Recall initiated: May 1, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Biomet, Inc.
- Distributor
- US Nationwide Distribution in the states of CA, TX, FL, NC, MI, GA.
- Lot
- Part 14-450510 Lots:268000, 466170, and 813950
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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