Mauch XG, Caron Knee Frame. Model numbers FDM01804U, FRM01804LU, FRM01851U, FRM61750.
This recall has been terminated (originally issued May 14, 2003).
- Company
- Ossur North America Inc
- Recall Initiated
- March 17, 2003
- Posted
- May 14, 2003
- Terminated
- April 14, 2004
- Recall Number
- Z-0815-03
- Quantity
- 261
- Firm Location
- Aliso Viejo, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Knee frame defect lead to breakage and injury. Knee bolt end came loose.
Distribution
Nationwide.
Lot / Code Info
No lot numbers apply, there are no serial numbers for this product. All frames manufactured since the product was released are suspect.
Root Cause
Other
Action Taken
Firm called customers by phone and sent recall letters 3/17/2003.
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