Scorpio Series 7000 Tibial Impactor/Extractor, Catalog number 3770-000 Non Sterile Howmedica Osteonics Corp. 325 Corpora

FDA device recall Z-0115-2009 · posted 2008-10-20 · Terminated

Recall details

Recalling firm

Stryker Howmedica Osteonics Corp.

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.

Action taken

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.

Root cause

Component design/selection

Status

Terminated

Product code

HWA

Quantity affected

5126

Distribution

Worldwide including the US and Asia Pacific, Canada, Europe, Middle East, Africa, Japan and Latin America.

Date initiated

2008-07-02

Date posted

2008-10-20

Date terminated

2012-08-17

Location

Mahwah, NJ