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U.S. Department of Health and Human Services

Class 2 Device Recall Biomet Rail System

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 Class 2 Recall
Biomet Rail System
see related information
Date Posted December 17, 2012
Recall Status1 Terminated on August 28, 2013
Recall Number Z-0527-2013
Recall Event ID 63725
Premarket Notification
510(K) Number
K000083 
Product Classification Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component - Product Code KTT
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.
Code Information Catalog Number 06350 and Lot Number Identification 994790 (packaged as 042210)
Recalling Firm/
Manufacturer
Biomet, Inc.
56 E Bell Dr
Warsaw, Indiana 46582-6989
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
It was reported that the number scale/graduation markings were missing on 14 pieces of the swivel clamp.
FDA Determined
Cause 2
DESIGN: Process Design
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.
Quantity in Commerce 49
Distribution Worldwide Distribution, including the states of TX, TN, PA, CA, NY, FL, and MI and the countries of Japan and Columbia.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KTT and Original Applicant = EBI, L.P.
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