Class 2 Device Recall Stryker VertePort

• Date Initiated by Firm: February 13, 2008
• Date Posted: March 11, 2008
• Recall Status: Terminated on December 30, 2008
• Recall Number: Z-1194-2008
• Recall Event ID: 46726
• Product Classification: Cement Mixer - Product Code JDZ
• Product: Stryker VertePort, 10 G Access Canula (short), REF 306-430, Qty 6; For use with the Stryker PCD Precision System and ACM Delivery System, Rx only, sterile, Stryker Instruments, Kalamazoo, MI.
• Code Information: All Lots-BCXE and BENB
• 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-labeling; 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: 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.