Class 2 Device Recall Stryker Orthopedics

• Date Initiated by Firm: December 15, 2014
• Date Posted: February 03, 2015
• Recall Status: Terminated on September 22, 2016
• Recall Number: Z-1043-2015
• Recall Event ID: 70100
• 510(K)Number: K983382
• Product Classification: Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate - Product Code MEH
• Product: Trident PSL HA Solid Back 50 mm Includes Dome Hole Plug Ref 540-11-50E Intended for cementless application in a total hip arthroplasty procedure. This system is a two piece ( a shell and a liner) design that is assembled during surgery. The shell is press-fit into the patients prepared acetabulum and a linger (polyethylene or alumina ceramic) is then locked into the shell. The femoral head component of the total hip system articulates with the acetabular liner.
• Code Information: 510K 983382 Lot code 49073501
• Recalling Firm/ Manufacturer: Stryker Howmedica Osteonics Corp.; 325 Corporate Dr; Mahwah NJ 07430-2002
• For Additional Information Contact: Mr. Paul Jahnke; 201-831-5000
• Manufacturer Reason for Recall: Five customer complaints were received for the same batch of Trident PSL Shells (part number 540-11-50E lot 49073501) alleging that when the packages were opened there were no dome holes plugs present.
• FDA Determined Cause: Process control
• Action: Stryker sent an Urgent Medical Device letter dated January 7, 2015, with a Recall Notification/Acknowledgement Form via Fed Ex to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete and return the attached Product Recall Acknowledgement Form to so_m_product_field_action_response@stryker.com or fax to 1-855-251-3635. Customers should return the affected product to: Attention: Regulatory Compliance Stryker Orthopaedics 325 Corporate Drive Mahwah, New Jersey 07430 Customers with questions should call 201-831-6365. For questions regarding this recall call 201-831-5000.
• Quantity in Commerce: seven units
• Distribution: Nationwide Distribution including NY, OH, PA, and TX.
• 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.

• 510(K) Database: 510(K)s with Product Code = MEH