Z-0115-2009

Scorpio Series 7000 Tibial Impactor/Extractor, Catalog number 3770-000 Non Sterile Howmedica Osteonics Corp...

Name: Z-0115-2009 Scorpio Series 7000 Tibial Impactor/Extractor, Catalog number 3770-000 Non Sterile Howmedica Osteonics Corp...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2008-07-02
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2008-07-02 / Terminated / root cause: design

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Scorpio Series 7000 Tibial Impactor/Extractor, Catalog number 3770-000 Non Sterile Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 The... on 2008-07-02. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0115-2009
Status: Terminated
Initiated: 2008-07-02
Posted: 2008-10-20
Terminated: 2012-08-17
Recalling firm: 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.
Product code: HWA Impactor
Reason for recall: 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 tag: design
FDA 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 in commerce: 5126
Distribution: Worldwide including the US and Asia Pacific, Canada, Europe, Middle East, Africa, Japan and Latin America.
Product codes and lots: All Lot Codes

Product code HWA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)