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U.S. Department of Health and Human Services

Class 2 Device Recall Patella Trial

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 Class 2 Device Recall Patella Trialsee related information
Date Initiated by FirmFebruary 22, 2010
Date PostedApril 07, 2010
Recall Status1 Terminated 3 on July 22, 2010
Recall NumberZ-1255-2010
Recall Event ID 54702
510(K)NumberK932246 
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
ProductFoundation Knee System, Patella Trial, 26 mm, part number 802-01-019, Lot number 53944551
Code Information Part Number 802-01-019  Lot 53944551
FEI Number 1000116912
Recalling Firm/
Manufacturer		 Encore Medical, Lp
9800 Metric Blvd
Austin TX 78758
For Additional Information Contact
512-832-9500
Manufacturer Reason
for Recall		One lot of product was incorrectly manufactured. Pegs are larger than specification.
FDA Determined
Cause 2		Process control
ActionFirm notified consignees by e-mail on 2/22/2010.
Quantity in Commerce2 units
DistributionUnited States (FL and ID).
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
510(K) Database510(K)s with Product Code = JWH
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