Mauch XG, Caron Knee Frame. Model numbers FDM01804U, FRM01804LU, FRM01851U, FRM61750.
FDA Recall Z-0815-03 · Posted 2003-05-14
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Recalling FirmOssur North America Inc
Recall StatusTerminated
Product CodeISY
Date Initiated2003-03-17
Date Terminated2004-04-14
Product Quantity261
Reason for Recall
Knee frame defect lead to breakage and injury. Knee bolt end came loose.
Firm Action
Firm called customers by phone and sent recall letters 3/17/2003.
Root Cause
Other
Distribution Pattern
Nationwide.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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