—#72482

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.

FDA product code: HWA — Impactor
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: All Lot Codes

Why it was recalled

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 (FDA determination)

Component design/selection

Action the firm took

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.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430-2002

Distribution

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

Timeline

Recall initiated: 2008-07-02
Posted by FDA: 2008-10-20
Terminated: 2012-08-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #72482. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.