Ossur North America Inc Mauch XG, Caron Knee Frame. Model numbers FDM01804U, FRM01804LU, FRM01851U, FRM61750. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Mauch XG, Caron Knee Frame. Model numbers FDM01804U, FRM01804LU, FRM01851U, FRM61750.
Brand
Ossur North America Inc
Lot Codes / Batch Numbers
No lot numbers apply
Products Sold
No lot numbers apply, there are no serial numbers for this product. All frames manufactured since the product was released are suspect.
Ossur North America Inc is recalling Mauch XG, Caron Knee Frame. Model numbers FDM01804U, FRM01804LU, FRM01851U, FRM61750. due to Knee frame defect lead to breakage and injury. Knee bolt end came loose.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Knee frame defect lead to breakage and injury. Knee bolt end came loose.
Recommended Action
Per FDA guidance
Firm called customers by phone and sent recall letters 3/17/2003.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026