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U.S. Department of Health and Human Services

Class 2 Device Recall Impactor

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 Class 2 Recall
Impactor
see related information
Date Posted September 29, 2008
Recall Status1 Terminated on August 03, 2009
Recall Number Z-2466-2008
Recall Event ID 49116
Premarket Notification
510(K) Numbers
K923277  K941306  K970031 
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product FOUNDATION KNEE SYSTEM Tibial Fixed Impactor, Revision A and B; Catalog #801-01-449; distributed by Encore Medical, L.P., Austin, TX 78758. The Tibial Fixed Impactor, a part of the FOUNDATION KNEE SYSTEM, is a manual orthopedic surgical instrument intended to lock onto the baseplate to impact the implant.
Code Information All Revision A and Revision B Impactors.
Recalling Firm/
Manufacturer
Encore Medical, Lp
9800 Metric Blvd
Austin, Texas 78758
Manufacturer Reason
for Recall
Complaints received regarding the fracture of the Nitronic 60 screw on the Tibial Fixed Impactor during surgery.
FDA Determined
Cause 2
DESIGN: Device Design
Action Recall notification sent via letter starting on 08/04/07. Consignees asked to quarantine and return affected devices. Contact Encore Medical, Lp at 1-512-834-6330 for assistance.
Quantity in Commerce 68 units.
Distribution FL and TX and OUS: 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.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = ENCORE ORTHOPEDICS, INC.
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