Mauch XG, Caron Knee Frame. Model numbers FDM01804U, FRM01804LU, FRM01851U, FRM61750.
FDA device recall Z-0815-03 · posted 2003-05-14 · Terminated
Recall details
- Recalling firm
- Ossur North America Inc
- Reason for recall
- Knee frame defect lead to breakage and injury. Knee bolt end came loose.
- Action taken
- Firm called customers by phone and sent recall letters 3/17/2003.
- Root cause
- Other
- Status
- Terminated
- Product code
- ISY
- Quantity affected
- 261
- Distribution
- Nationwide.
- Date initiated
- 2003-03-17
- Date posted
- 2003-05-14
- Date terminated
- 2004-04-14
- Location
- Aliso Viejo, CA
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