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U.S. Department of Health and Human Services

Class 2 Device Recall Disposable Coring Trephine

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 Class 2 Recall
Disposable Coring Trephine
see related information
Date Posted September 28, 2010
Recall Status1 Terminated on August 20, 2012
Recall Number Z-2598-2010
Recall Event ID 56522
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product 8 MM DISPOSABLE CORING TREPHINE WITH PROTECTION SLEEVE, REF 900728, Sterile, BIOMET Sports Medicine, Warsaw, IN 46581. Usage: Bone Coring Device used in ACL and PCL procedures.
Code Information 648180 and 648200.
Recalling Firm/
Manufacturer
Biomet, Inc.
56 E Bell Dr
Warsaw, Indiana 46582
For Additional Information Contact Mary Johnson
574-267-6639 Ext. 1676
Manufacturer Reason
for Recall
The affected instruments are discolored and/or have a sticky residue on the end.
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Packaging Change Control
Action The firm sent out "Urgent Medical Device Recall" notices dated 7/1/2010. Letters were sent to distributors, customers and OR managers. The letters stated that the devices should be located, quarantined and shipped back to the recalling firm. On 7/15/2010, the firm added one lot of one additional product to the recall (product 900788 lot 780470). The firm sent letters to physicians that had used that lot of product. Questions relating to this recall should be directed to 574-371-3755.
Quantity in Commerce 100
Distribution US, Canada, Australia, Chile, Argentina, Netherlands, Costa Rica and Japan.
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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