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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 Device Recall Scorpio Series 7000 see related information
Date Initiated by Firm July 02, 2008
Date Posted October 20, 2008
Recall Status1 Terminated 3 on August 17, 2012
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 NJ 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		 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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