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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 FirmSeptember 19, 2003
Date PostedJanuary 14, 2004
Recall Status1 Terminated 3 on March 03, 2005
Recall NumberZ-0339-04
Recall Event ID 27848
Product Classification Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented - Product Code LWJ
ProductHip Stem, Sterile Pkg. The implant consists of 2 metal componets which fit together to for a femoral stem.
Code Information Catalog numbers, 11911, 11912, 11913, 11914, 11930, 11931
Recalling Firm/
Manufacturer		 Plus Orthopedics
6055 Lusk Blvd
San Diego CA 92121
For Additional Information ContactNeil Delaney
888-741-7587
Manufacturer Reason
for Recall		Design Change
FDA Determined
Cause 2		Other
ActionNotify all implanting physicians of the removal and weight restrictions, and to evaluate thier patients for adherence to the weight restriction.
Quantity in Commerce53
DistributionCA, AZ, NV, NV, CO
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.
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