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 Recall Z-0115-2009 · Posted 2008-10-20
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Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeHWA
Date Initiated2008-07-02
Date Terminated2012-08-17
Product Quantity5126
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.
Firm 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.
Root Cause
Component design/selection
Distribution Pattern
Worldwide including the US and Asia Pacific, Canada, Europe, Middle East, Africa, Japan and Latin America.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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