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U.S. Department of Health and Human Services

Class 2 Device Recall Patella Trial

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 Class 2 Recall
Patella Trial
see related information
Date Posted April 07, 2010
Recall Status1 Terminated on July 22, 2010
Recall Number Z-1255-2010
Recall Event ID 54702
Premarket Notification
510(K) Number
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product Foundation Knee System, Patella Trial, 26 mm, part number 802-01-019, Lot number 53944551
Code Information Part Number 802-01-019 Lot 53944551
Recalling Firm/
Encore Medical, Lp
9800 Metric Blvd
Austin, Texas 78758
Manufacturer Reason
for Recall
One lot of product was incorrectly manufactured. Pegs are larger than specification.
FDA Determined
Cause 2
Action Firm notified consignees by e-mail on 2/22/2010.
Quantity in Commerce 2 units
Distribution United States (FL and ID).
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.