Class 2 Device Recall ACCOLADE TMZF HA 132 DEGREE SIZE 0 HIP STEM

• Date Initiated by Firm: January 06, 2009
• Date Posted: July 22, 2009
• Recall Status: Terminated on June 25, 2012
• Recall Number: Z-1358-2009
• Recall Event ID: 50901
• 510(K)Number: K020572
• Product Classification: Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate - Product Code MEH
• Product: Accolade TMZF Hip Stem; Hydroxylapatite Coated, Titanium Plasma Spray, V40 Taper, Sterile. 132 degree neck angle. Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a previous total hip arthroplasty.
• Code Information: 6020-0537 ACCOLADE 132 SIZE 5 25189704 and 6020-0537 ACCOLADE 132 SIZE 5 25189705.
• Recalling Firm/ Manufacturer: Stryker Howmedica Osteonics Corp.; 325 Corporate Dr; Mahwah NJ 07430
• For Additional Information Contact: Colleen O'Meara; 201-831-5000
• Manufacturer Reason for Recall: Product deviation : Specific lots of sprayed HA hip stems did not meet Stryker's Internal Material Specification for tensile bond strength and crystallinity.
• FDA Determined Cause: Process control
• Action: An "Urgent Product Recall" letter was sent via Federal Express on January 6, 2009 with return receipt to Stryker Branches/Agencies, Hospital Risk Management, Hospital Chief of Orthopaedics and Surgeons. The letter described the affected product, issue, potential hazards and risks. Stryker Branches and Hospital Risk Management were asked to examine their inventory for affected product. Stryker Representatives were instructed to contact customers to reconcile and return recalled product to Stryker Orthopaedics. All letters include a response form to be completed and returned indicating that they have been informed of the recall and the amount of product on hand, if any. Direct questions about the recall to Stryker Orthopaedics at 1-201-831-5718.
• Quantity in Commerce: 1,628 total stems, all varieties.
• Distribution: Nationwide Distribution.
• 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