Device 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.
Z-0527-2013
Product summary
- Firm
- Biomet, Inc.
- Event
- Event 63725
- Status
- Terminated
- Classification
- Class II
- Quantity
- 49
- Official record key
device-enforcement:Z-0527-2013
Official wording
Reason: It was reported that the number scale/graduation markings were missing on 14 pieces of the swivel clamp.
Code information: Catalog Number 06350 and Lot Number Identification 994790 (packaged as 042210)
Distribution pattern: Worldwide Distribution, including the states of TX, TN, PA, CA, NY, FL, and MI and the countries of Japan and Columbia.
Derived failure modes
-
Unknown
It was reported that the number scale/graduation markings were missing on 14 pieces of the swivel clamp.