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U.S. Department of Health and Human Services

Class 2 Device Recall Scorpio Series 7000

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 Class 2 Recall
Scorpio Series 7000
see related information
Date Posted October 20, 2008
Recall Status1 Open
Recall Number Z-0115-2009
Recall Event ID 48995
Product Classification Impactor - Product Code HWA
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.
Code Information All Lot Codes
Recalling Firm/
Manufacturer
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah, New Jersey 07430-2002
For Additional Information Contact Brian McGuire
201-831-5918
Manufacturer 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.
FDA Determined
Cause 2
DESIGN: 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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