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U.S. Department of Health and Human Services

Class 2 Device Recall Biomet Offset Tibial Tray Adaptor

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 Class 2 Recall
Biomet Offset Tibial Tray Adaptor
see related information
Date Posted December 17, 2012
Recall Status1 Terminated on November 08, 2013
Recall Number Z-0533-2013
Recall Event ID 63781
Premarket Notification
510(K) Number
K010212 
Product Classification Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer - Product Code MBV
Product Biomet Offset Tibial Tray 2.5 mm Adaptor, REF 141490 Sterile, QTY.1 Product Usage: Knee joint replacement prostheses intended for application with or without bone cement. Knee joint replacement components include femoral, tibial, and patellar components, intended for both primary and revision applications. Indications: 1) painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis when one or more compartments are involved, 2) correction of varus, valgus, or posttraumatic deformity, 3) correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure
Code Information Catalog Number: 141490 Lot 378330,378320,407230,485010,505140,485000,506070,533400,54048, 439700,797820
Recalling Firm/
Manufacturer
Biomet, Inc.
56 E Bell Dr
Warsaw, Indiana 46582-6989
For Additional Information Contact Audrey Daenzer
574-372-1570
Manufacturer Reason
for Recall
Biomet investigation identified that the square end of the offset tibial tray adaptor locking insert is oversized and may not engage insert tool screwdriver. This could cause a possible delay in surgery greater than 30 minutes, potentially exposing the patient to the increased risks from being under anesthesia for a longer duration.
FDA Determined
Cause 2
TRAINING: Employee Error
Action Biomet Recall sent an Urgent Medical Device Recall Notices letter dated November 15, 2012 to distributors, hospital operating room(OR)managers and Surgeons receiving the affected product. The letter identified the affected product, the reason for the recall and actions to be take, including directions to immediately locate and discontinue use of the affected product. Customers were asked to confirm receipt of the notice by calling 1-888-348-9500 extension 1570. Customers with affected product to be returned are asked to obtain RGA # by calling 574-372-6677 or email: rgarequest@biomet.com. A FAX Back Response Form is to be filled out and sent within 3 days of receipt to 574-372-1683. Return product to the Attention of Audrey Daenzer, Field Action Coordinator, Biomet, Attention Return Goods, Building B Recalls, 56 East Bell Drive, Warsaw, IN 46580. Questions related to the notice should be directed to 474-372-3983 or 574-371-3009, Monday- Friday 8 a.m. to 5 p.m.
Quantity in Commerce 200
Distribution Worldwide distribution - USA (nationwide) and the countries of Australia, Canada, Chile, Europe, Japan, Korea, Panama, Puerto Rico and Thailand.
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 = MBV and Original Applicant = BIOMET, INC.
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