Z-0527-2013 Class II Terminated
FDA device recall Z-0527-2013 was initiated by Biomet, Inc. on Nov 9, 2012 and is designated Class II. Reason for recall: It was reported that the number scale/graduation markings were missing on 14 pieces of the swivel clamp. The recall status is terminated (terminated Aug 28, 2013). Affected quantity: 49.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 26, 2012
- Initiation Date
- Nov 9, 2012
- Termination Date
- Aug 28, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 49
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.
Distribution Pattern
Worldwide Distribution, including the states of TX, TN, PA, CA, NY, FL, and MI and the countries of Japan and Columbia.
Code Information
Catalog Number 06350 and Lot Number Identification 994790 (packaged as 042210)
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0527-2013
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026