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
Reported: June 17, 2015 Initiated: May 1, 2015 #Z-1741-2015
Product Description
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
Reason for Recall
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.
Details
- Recalling Firm
- Biomet, Inc.
- Units Affected
- 19
- Distribution
- US Nationwide Distribution in the states of CA, TX, FL, NC, MI, GA.
- Location
- Warsaw, IN
Frequently Asked Questions
What product 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. Recalled by Biomet, Inc.. Units affected: 19.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 17, 2015. Severity: Moderate. Recall number: Z-1741-2015.
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