FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: Duracon Total Knee Modular Femoral Component; Non-Porous Right Medium Assembly, Product No. 6632-0-325
- Recall number
- Z-1241-2007
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Product
- Duracon Total Knee Modular Femoral Component; Non-Porous Right Medium Assembly, Product No. 6632-0-325
- Status
- Terminated
- Initiated
- 2006-10-17
- Posted
- 2007-09-21
- Terminated
- 2009-07-07
- Reason
- Loose fixation pegs: One lot of femoral components may have loose fixation pegs.
- Root cause
- Other
- Action
- Notification letters, dated 10/17/2006, were sent via Federal Express on 10/17/2006 to all consignees requesting return of product.
- Quantity
- 3 total, 2 in USA
- Distribution
- Worldwide : One Hospital in Georgia (USA), Stryker Branch in Indiana and Stryker Branch in Sweden.
- Lot, serial or model codes
- Product No. 6632-0-325; Lot code UCVO
- 510(k) numbers
- ["K920034"]
- PMA numbers
- not on file
- Product code
- JWH
- Firm FEI
- 3003070421
- Firm city
- Mahwah
- Firm state
- NJ
- 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