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.
FDA Recall Z-0527-2013 · Posted 2012-12-17
Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeKTT
Date Initiated2012-11-09
Date Terminated2013-08-28
Product Quantity49
Reason for Recall
It was reported that the number scale/graduation markings were missing on 14 pieces of the swivel clamp.
Firm 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.
Root Cause
Process design
Distribution Pattern
Worldwide Distribution, including the states of TX, TN, PA, CA, NY, FL, and MI and the countries of Japan and Columbia.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.