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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm March 17, 2003
Date Posted May 14, 2003
Recall Status1 Terminated 3 on April 14, 2004
Recall Number Z-0815-03
Recall Event ID 25940
Product Classification Joint, Knee, External Limb Component - Product Code ISY
Product Mauch XG, Caron Knee Frame.

Model numbers FDM01804U, FRM01804LU, FRM01851U, FRM61750.
Code Information No lot numbers apply, there are no serial numbers for this product. All frames manufactured since the product was released are suspect.
Recalling Firm/
Manufacturer		 Ossur North America Inc
27412 Laguna Hills Dr
Aliso Viejo CA 92656
Manufacturer Reason
for Recall		 Knee frame defect lead to breakage and injury. Knee bolt end came loose.
FDA Determined
Cause 2		 Other
Action Firm called customers by phone and sent recall letters 3/17/2003.
Quantity in Commerce 261
Distribution Nationwide.
Total Product Life Cycle TPLC 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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