Class 2 Device Recall Total Hip Joint Replacement

• Date Initiated by Firm: July 14, 2011
• Date Posted: October 20, 2011
• Recall Status: Terminated on November 15, 2013
• Recall Number: Z-0075-2012
• Recall Event ID: 59968
• 510(K)Number: K994366
• Product Classification: Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate - Product Code MEH
• Product: Total Hip Joint Replacement Accolade TMZF Plus 127 Neck Angle V40 Hip Stem #3 Accolade TMZF Plus 127 Neck Angle V40 Hip Stem #5 Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 A subsidiary of Stryker Corp. Stryker France ZAC Satolos Green Pusignan Av de Staolas Green 69881 Metziae Cedex France The TMZF Press Fit HA Stem and TMZF Press Fit Plus HA Stem are intended for the reconstruction of the head and neck of the femoral joint. The device is intended for primary reconstruction of the proximal femur or revision of a previous total hip arthroplasty. These stems can be used with any currently available Howmedica Osteonics acetabular components and V40 Femoral Heads that can be mated with a 5 40 BG taper.
• Code Information: K994366 6021-0335 6021-0537 Accolade TMZF Plus 127 Neck Angle V40 Hip Stem #3; Catalog #6021-0335 Lot Code 35427003; Accolade TMZF Plus 127 Neck Angle V40 Hip Stem #5; Catalog #6021-0537 Lot Code 35202601
• Recalling Firm/ Manufacturer: Stryker Howmedica Osteonics Corp.; 325 Corporate Drive; Mahwah NJ 07430
• For Additional Information Contact: Ms. Colleen O' Meara; 201-972-2100
• Manufacturer Reason for Recall: Stryker Orthopaedics has become aware that a size 3 Accolade stem was in a box labeled as a size 5 Accolade stem.
• FDA Determined Cause: Mixed-up of materials/components
• Action: Stryker Orthopaedics sent an "URGENT: PRODUCT RECALL" letter dated July 14, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to complete and return an attached Product Recall Acknowledgment Form via fax to 201-831-6069. Additionally, information is provided for customers to return the affected products. Please contact the Divisional Regulatory Compliance Manager at 201-972-2100 for questions regarding this notice.
• Quantity in Commerce: 21 units
• 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