Class 2 Device Recall Stryker ACM bowl without cartridge

• Date Initiated by Firm: January 10, 2008
• Date Posted: May 01, 2008
• Recall Status: Terminated on July 31, 2008
• Recall Number: Z-1106-2008
• Recall Event ID: 46340
• Product Classification: bone cement accessory - Product Code JDZ
• Product: Stryker Advanced Cement Mixer (ACM) Bowl and Base without 180 Gram Cement Cartridge for use with Stryker High Vacuum Cement Injection System, sterile; REF 306-554, Stryker Instruments, Kalamazoo, MI 49001.
• Code Information: Lot Numbers: 05167CG2, 05192012, 05223012 and 06335012.
• FEI Number: 1811755
• Recalling Firm/ Manufacturer: Stryker Instruments Div. of Stryker Corporation; 4100 E. Milham Ave.; Portage MI 49002-9704
• For Additional Information Contact: 800-800-4236 Ext. 3808
• Manufacturer Reason for Recall: Sterility may be compromised, as the packaging may have channels in the packaging seal.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Stryker notified consignees via Medical Device Recall Notification letter dated 1/10/08 to quarantine the product and to return it.
• Quantity in Commerce: 25 boxes of 6 each
• Distribution: Nationwide Distribution - Illinois, Michigan, New York, Ohio and Wyoming.
• 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.