FDA Medical Device Recalls (openFDA)
Ossur North America Inc: Mauch XG, Caron Knee Frame. Model numbers FDM01804U, FRM01804LU, FRM01851U, FRM61750.
- Recall number
- Z-0815-03
- Recalling firm
- Ossur North America Inc
- Product
- Mauch XG, Caron Knee Frame. Model numbers FDM01804U, FRM01804LU, FRM01851U, FRM61750.
- Status
- Terminated
- Initiated
- 2003-03-17
- Posted
- 2003-05-14
- Terminated
- 2004-04-14
- Reason
- Knee frame defect lead to breakage and injury. Knee bolt end came loose.
- Root cause
- Other
- Action
- Firm called customers by phone and sent recall letters 3/17/2003.
- Quantity
- 261
- Distribution
- Nationwide.
- Lot, serial or model codes
- No lot numbers apply, there are no serial numbers for this product. All frames manufactured since the product was released are suspect.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- ISY
- Firm FEI
- 1000519909
- Firm city
- Aliso Viejo
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28