FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: Scorpio Total Knee Posteriorly Stabilized Femoral Component, #7R, Catalog No.: 71-4107R, Lot Code: K05L310; Scorpio Total Knee Posteriorly Stabilized Femoral Component, #7L, Catalog No. 71-4506L, Lot Code K05L224.
- Recall number
- Z-1814-2008
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Product
- Scorpio Total Knee Posteriorly Stabilized Femoral Component, #7R, Catalog No.: 71-4107R, Lot Code: K05L310; Scorpio Total Knee Posteriorly Stabilized Femoral Component, #7L, Catalog No. 71-4506L, Lot Code K05L224.
- Status
- Terminated
- Initiated
- 2005-11-08
- Posted
- 2008-09-11
- Terminated
- 2010-05-13
- Reason
- Mislabeled boxes -- Scorpio PS Right Femoral Component No Posts contained a Scorpio PS Left Femoral Component with Posts and vice versa.
- Root cause
- Employee error
- Action
- Consignees were notified by letter sent via Federal Express with return receipt on November 8, 2005. All consginees who received the subject devices were provided Product Accountability forms to be returned to the firm.
- Quantity
- 8 units
- Distribution
- Worldwide Distribution
- Lot, serial or model codes
- Catalog No: 71-4107R, Lot Code: K05L310; Catalog No: 71-4506L, Lot Code K05L224
- 510(k) numbers
- ["K962152"]
- PMA numbers
- not on file
- Product code
- KWY
- 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