FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: Scorpio Total Knee Posteriorly Stabilized Femoral Component; Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis; Product Number: 71-4507R; Stryker Corp, Howmedica Osteonics Corp, Mahwah, NJ 07430.
- Recall number
- Z-1382-2008
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Product
- Scorpio Total Knee Posteriorly Stabilized Femoral Component; Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis; Product Number: 71-4507R; Stryker Corp, Howmedica Osteonics Corp, Mahwah, NJ 07430.
- Status
- Terminated
- Initiated
- 2005-02-08
- Posted
- 2008-07-16
- Terminated
- 2008-07-16
- Reason
- Mislabeled: The labeling indicates a Scorpio PS Femoral Component, however, the device inside the package is actually a Scorpio CR Femoral Component.
- Root cause
- Labeling mix-ups
- Action
- Consignees were notified by letter on 2/8/05. For additional information contact 201-831-5825.
- Quantity
- 5 units
- Distribution
- Worldwide Distribution including USA and countries of Canada, Mexico, Italy, The Netherlands and the UK.
- Lot, serial or model codes
- Lot Number: K04W718.
- 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