FDA Medical Device Recalls (openFDA)
Biomet, Inc.: 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
- Recall number
- Z-1741-2015
- Recalling firm
- Biomet, Inc.
- 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
- Status
- Terminated
- Initiated
- 2015-05-01
- Posted
- 2015-06-09
- Terminated
- 2015-12-08
- Reason
- 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.
- Root cause
- Process control
- Action
- Biomet sent an URGENT MEDICAL DEVICE RECALL NOTICE letter dated May 1, 2015 to the affected distributors and implanting surgeons. The recall letter included a description of the reason for the recall, affected product, consignee responsibilities, and distributor instructions for responding to the formal recall notification. Consignees were instructed to return the affected product and continued monitoring of patients. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.
- Quantity
- 19
- Distribution
- US Nationwide Distribution in the states of CA, TX, FL, NC, MI, GA.
- Lot, serial or model codes
- Part 14-450510 Lots:268000, 466170, and 813950
- 510(k) numbers
- ["K111376"]
- PMA numbers
- not on file
- Product code
- KTT
- Firm FEI
- 1825034
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28