FDA Medical Device Recalls (openFDA)
Biomet, Inc.: EBI XFIX DFS Rail System (Adult Rail Gradual Swivel Clamp). The Biomet Rail System consists of a unilateral external fixator rail, modular bone screw clamps, and compression and distraction units. The device is used in the treatment of bone fractures.
- Recall number
- Z-0527-2013
- Recalling firm
- Biomet, Inc.
- Product
- EBI XFIX DFS Rail System (Adult Rail Gradual Swivel Clamp). The Biomet Rail System consists of a unilateral external fixator rail, modular bone screw clamps, and compression and distraction units. The device is used in the treatment of bone fractures.
- Status
- Terminated
- Initiated
- 2012-11-09
- Posted
- 2012-12-17
- Terminated
- 2013-08-28
- Reason
- It was reported that the number scale/graduation markings were missing on 14 pieces of the swivel clamp.
- Root cause
- Process design
- Action
- On 11/9/2012 an URGENT MEDICAL DEVICE RECALL NOTIFICATION letter was sent to all consignees (distributors and Doctor notices) informing them of the issue and providing recommended actions. Customer contact number (574) 372-1570 Monday through Friday from 8 am to 5 pm.
- Quantity
- 49
- Distribution
- Worldwide Distribution, including the states of TX, TN, PA, CA, NY, FL, and MI and the countries of Japan and Columbia.
- Lot, serial or model codes
- Catalog Number 06350 and Lot Number Identification 994790 (packaged as 042210)
- 510(k) numbers
- ["K000083"]
- 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