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U.S. Department of Health and Human Services

Class 2 Device Recall Offset reamer brushing angled

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 Class 2 Recall
Offset reamer brushing angled
see related information
Date Posted December 28, 2010
Recall Status1 Terminated on January 19, 2011
Recall Number Z-0829-2011
Recall Event ID 57273
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product Vanguard Knee Instruments offset reamer bushing - angled, REF 32-488519, Biomet Bridgend, UK. This instrument is used to prepare the tibial cancellous bone for the tibial offset tray.
Code Information 1723336, 1768306, 2049011, ZB090424.
Recalling Firm/
Manufacturer
Biomet, Inc.
56 E Bell Dr
Warsaw, Indiana 46582
For Additional Information Contact David Broderick
574-267-6639 Ext. 1676
Manufacturer Reason
for Recall
The firm has initiated the action following a report that during surgery the Offset Reamer Brushign would not mate with the prepartion mask. After a 5 minute delay in surgery the procedure was completed using another attachment that was on hand. There was no injury to the patient.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action The firm, BIOMET, sent a "FIELD SAFETY NOTICES" dated September 10, 2010, addressed to the head of orthopaedic departments, trauma departments, operating departments, sterile service departments, procurement, supplies and risk management. The notice described the product, problem and action to be taken by the customers. The letters instructed the customers to locate and immediately quarantine the recalled device; to complete and return the attached "FAX BACK RESPONSE FORM" via fax to +44 (0) 1656 645454, and the recalled device for credit via mail to Biomet UK Ltd, Waterton Industrial Estate, Bridgend, CF31 3XA. The customers were also instructed to inform all in their organization who are using or ordering the products and send a copy to the organization to which potentially affected products may have been transferred. If you have any questions regarding this communication, please contact the Quality Manager at +44 (0) 1656 655221 or email: david.broderick@biomet.com.
Quantity in Commerce 16 units
Distribution International distribution only: Netherlands, Germany, France, Spain, Italy and Denmark
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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