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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
Consumer Instructions Contact the recalling firm for information
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.