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U.S. Department of Health and Human Services

Class 2 Device Recall Stright Ringloc Button Latch Inserter Handle

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 Class 2 Recall
Stright Ringloc Button Latch Inserter Handle
see related information
Date Posted March 08, 2013
Recall Status1 Terminated on September 30, 2013
Recall Number Z-0925-2013
Recall Event ID 64354
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product REF S313152 Straight Acetabular Inserter Handle Ringloc non-sterile Orthopedic manual surgical instrument
Code Information Catalog Number 5313152 Lot 153880,153930, 415500, 648010
Recalling Firm/
Manufacturer
Biomet, Inc.
56 E Bell Dr
Warsaw, Indiana 46582-6989
For Additional Information Contact Audrey Daenzer
574-267-6639 Ext. 1676
Manufacturer Reason
for Recall
The Straight Ringloc Button Latch Inserter Handle may have been manufactured at the higher end of the tolerance causing interference with the Ringloc cup. The inserter handle may lock onto the cup during impaction. If alternative inserters are not available this could cause a surgical delay greater than 30 minutes.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action BIOMET sent an Urgent Recall Notice beginning February 13, 2013, to all affected customers. The notice included possible adverse events and directions to locate and remove identified devices by returning a Fax Back Response Form to 574-372-1683 and obtaining an RGA # prior to return of product to Biomet, Inc. 56 East Bell Drive Warsaw, IN 46580. Questions should be directed to 574 372-1570 M-F, 8 a.m.-5.p.m. For questions regarding this recall call 574-267-6639, ext 1676.
Quantity in Commerce 58
Distribution Worldwide Distribution - No USA distribution -Internationally to Canada, Japan, and Chile
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.
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