Z-0815-03

Mauch XG, Caron Knee Frame. Model numbers FDM01804U, FRM01804LU, FRM01851U, FRM61750

Name: Z-0815-03 Mauch XG, Caron Knee Frame. Model numbers FDM01804U, FRM01804LU, FRM01851U, FRM61750
Creator: Ossur North America Inc
Published: 2003-03-17
License: https://open.fda.gov/license/

Ossur Americas / initiated 2003-03-17 / Terminated

FDA source

Ossur North America Inc began a recall of Mauch XG, Caron Knee Frame. Model numbers FDM01804U, FRM01804LU, FRM01851U, FRM61750 on 2003-03-17. The reason FDA records is "Knee frame defect lead to breakage and injury. Knee bolt end came loose". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0815-03
Status: Terminated
Initiated: 2003-03-17
Posted: 2003-05-14
Terminated: 2004-04-14
Recalling firm: Ossur Americas
Product: Mauch XG, Caron Knee Frame. Model numbers FDM01804U, FRM01804LU, FRM01851U, FRM61750.
Product code: ISY Joint, Knee, External Limb Component
Reason for recall: Knee frame defect lead to breakage and injury. Knee bolt end came loose.
FDA root cause: Other
Action: Firm called customers by phone and sent recall letters 3/17/2003.
Quantity in commerce: 261
Distribution: Nationwide.
Product codes and lots: No lot numbers apply, there are no serial numbers for this product. All frames manufactured since the product was released are suspect.

Product code ISY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)