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.
Reported: December 26, 2012 Initiated: November 9, 2012 #Z-0527-2013
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.
Details
- Recalling Firm
- Biomet, Inc.
- Units Affected
- 49
- Distribution
- Worldwide Distribution, including the states of TX, TN, PA, CA, NY, FL, and MI and the countries of Japan and Columbia.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Biomet, Inc.. Units affected: 49.
Why was this product recalled? ▼
It was reported that the number scale/graduation markings were missing on 14 pieces of the swivel clamp.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 26, 2012. Severity: Moderate. Recall number: Z-0527-2013.
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