Recall Z-0527-2013— Biomet, Inc.
Class II · Terminated
Class II FDA medical device recall by Biomet, Inc., initiated 2012-11-09, terminated 2013-08-28. It names one FDA 510(k) clearance: K000083. 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.. Reason: It was reported that the number scale/graduation markings were missing on 14 pieces of the swivel clamp..
- Recalling firm
- Biomet, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-11-09
- Terminated
- 2013-08-28
- Firm location
- Warsaw, IN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
It was reported that the number scale/graduation markings were missing on 14 pieces of the swivel clamp.
Data sourced from openFDA. This site is unofficial and independent of the FDA.