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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmJune 07, 2005
Date PostedJuly 21, 2005
Recall Status1 Terminated 3 on May 02, 2006
Recall NumberZ-1029-05
Recall Event ID 32282
PMA NumberP830055/R44 
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing - Product Code NJL
ProductDepuy brand LCS Complete metal backed patella, cemented, STD+; REF 1294-09-750.
Code Information Lots 1837372, 1840611, 1848388, 1855864, 1855865 and 1859890. 
Recalling Firm/
Manufacturer		 Depuy Orthopaedics, Inc.
700 Orthopaedic Dr
Warsaw IN 46582-3994
For Additional Information Contact
800-366-8143
Manufacturer Reason
for Recall		There may be dissociation of the polyethylene from the baseplate because the inside diameter of the polyethylene articular bearing was manufactured to an oversized condition.
FDA Determined
Cause 2		Other
ActionHospitals were notified via letter dated June 10, 2005 requesting that they quarantine product on hand and send in a response card to the firm.
DistributionNationwide and international.
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.
PMA DatabasePMAs with Product Code = NJL
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