Z-1741-2015 Class II Terminated
FDA device recall Z-1741-2015 was initiated by Biomet, Inc. on May 1, 2015 and is designated Class II. 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… The recall status is terminated (terminated Dec 8, 2015). Affected quantity: 19.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 17, 2015
- Initiation Date
- May 1, 2015
- Termination Date
- Dec 8, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19
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.
Distribution Pattern
US Nationwide Distribution in the states of CA, TX, FL, NC, MI, GA.
Code Information
Part 14-450510 Lots:268000, 466170, and 813950
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1741-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026