Reported Jun 17, 2015 · Terminated
Unilateral external fixation ankle clamp Product Usage: Unilateral external fixation for use treatment of bone…
Biomet, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Biomet, Inc. · 56 E Bell Dr · Warsaw, IN · 46582-6989
Is this the product you have?
- Unilateral external
- fixation ankle clamp Product UsageUnilateral external fixation for use treatment of bone conditions amenable to treatment by use of external fixation modality
- Lot codes and dates
- Part 14-450510 Lots
268000466170and 813950
- Part 14-450510 Lots
- Amount recalled
- 19
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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