FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: Osteonics Scorpio Total Knee; Posteriorly Stabilized Femoral Component; #13 with posts, low friction Ion treatment. Use only with Scorpio Posteriorly Stabilized Tibial Bearing Components with Scorpio Patellar Components.
- Recall number
- Z-2079-2008
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Product
- Osteonics Scorpio Total Knee; Posteriorly Stabilized Femoral Component; #13 with posts, low friction Ion treatment. Use only with Scorpio Posteriorly Stabilized Tibial Bearing Components with Scorpio Patellar Components.
- Status
- Terminated
- Initiated
- 2005-03-17
- Posted
- 2008-09-16
- Terminated
- 2008-09-24
- Reason
- Scorpio Posterior Stabilized Femoral Component labeled and laser marked as a Left, was in fact a Right component.
- Root cause
- Process control
- Action
- The International Stryker Distributor was notified via an advisory notice with return receipt on March 18, 2005
- Quantity
- 1 unit
- Distribution
- The one unit was distributed to an International Stryker branch.
- Lot, serial or model codes
- Catalog No. 711-4513L; Lot Code: K04S174
- 510(k) numbers
- ["K962152"]
- 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