FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: Scorpio Series 7000 Tibial Impactor/Extractor, Catalog number 3770-000 Non Sterile Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 The Impactor/Extractor is used for insertion and removal of a tibial baseplate during total knee arthroplasty.
- Recall number
- Z-0115-2009
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Product
- Scorpio Series 7000 Tibial Impactor/Extractor, Catalog number 3770-000 Non Sterile Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 The Impactor/Extractor is used for insertion and removal of a tibial baseplate during total knee arthroplasty.
- Status
- Terminated
- Initiated
- 2008-07-02
- Posted
- 2008-10-20
- Terminated
- 2012-08-17
- Reason
- Stryker Orthopaedics became aware that there is a potential inability to release the Scorpio Series 7000 Tibial Impactor/Extractor from a tibial baseplate during use.
- Root cause
- Component design/selection
- Action
- US recall notification (product correction) letters were send out by Federal Express with return receipt on July 2 and 9, 2008. Advisory notices were sent to foreign customers on July 2, 2008. Both letters include a Product Correction Bulletin that instructs all used to lubricate the divide with an approved medical lubricant, especially the extractor shaft and threads. It is recommended that all moving parts be evaluated for functionality and useful service prior to each surgery and instructions on how to perform this process. Contact Stryker Howmedica Osteonics Corp. at 1-201-831-5918 for assistance.
- Quantity
- 5126
- Distribution
- Worldwide including the US and Asia Pacific, Canada, Europe, Middle East, Africa, Japan and Latin America.
- Lot, serial or model codes
- All Lot Codes
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HWA
- 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