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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker VertePort

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  Class 2 Device Recall Stryker VertePort see related information
Date Initiated by Firm February 13, 2008
Date Posted March 11, 2008
Recall Status1 Terminated 3 on December 30, 2008
Recall Number Z-1195-2008
Recall Event ID 46726
Product Classification Cement Mixer - Product Code JDZ
Product Stryker VertePort , 11 G Cement Cannula, REF 306-510 , Qty 18; For use with the Stryker PCD Precision System and ACM Delivery System, Rx only, sterile, Stryker Instruments, Kalamazoo, MI.
Code Information All Lots-BB43, BDL5, BE0M, BE1D, BE77, BF4K, BMWJ, BNW8, BNW9 and BQ5W
Recalling Firm/
Manufacturer		 Stryker Instruments Div. of Stryker Corporation
4100 E Milham Ave
Portage MI 49002-9704
For Additional Information Contact Jennifer Mars
800-800-4236 Ext. 3808
Manufacturer Reason
for Recall		 Mis-labeing; The instructions for use include a use for which the device is not intended. (Device not approved to capture a bone biopsy)
FDA Determined
Cause 2		 Labeling Change Control
Action Consignees were notified via Medical Device Recall Notification letter dated 2/13/08 to read the enclosed instructions for use, remove all old instructions for use at the consignee location and replace them with the new instructions for use, and to discard the old instructions for use.
Quantity in Commerce 953 boxes Recalls Z-1192-1195-2008
Distribution Nationwide.
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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