Biomet Recalls Unilateral External Fixation Ankle Clamps Due to Assembly Error
Biomet, Inc. is recalling 19 unilateral external fixation ankle clamps because they were assembled incorrectly. The defect may prevent full range of motion and cause the pin to loosen from the bone.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device defect that may require revision surgery, representing a risk of harm where injury has not yet been reported, consistent with the High severity criteria.
Plain-English summary
Biomet, Inc. is recalling 19 units of the Unilateral External Fixation Ankle Clamp (Part 14-450510). The affected lots are 268000, 466170, and 813950. These devices are used for the treatment of bone conditions amenable to external fixation.
The recall is due to an assembly error where the offset of the pin to the pivot point is reversed. This defect prevents the device from achieving a complete range of motion. If the device is pushed too far, the pin may loosen from the bone, potentially requiring revision surgery to reconnect the fixator.
The affected products were distributed nationwide in California, Texas, Florida, North Carolina, Michigan, and Georgia. Healthcare providers and patients should stop using these specific units and contact Biomet, Inc. for instructions on how to proceed.
The recalled product
- 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
- Biomet, Inc.
- Affected units
- 19
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Part 14-450510 Lots:268000
- 466170
- and 813950
Distribution
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