Class 2 Device Recall Zimmer Trabecular Metal Modular Acetabular System

• Date Initiated by Firm: September 01, 2011
• Date Posted: September 27, 2011
• Recall Status: Terminated on August 29, 2013
• Recall Number: Z-3279-2011
• Recall Event ID: 59503
• 510(K)Number: K021891
• Product Classification: Prothesis, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
• Product: The Trabecular Metal Modular Acetabular System is a modular acetabular cup system consisting of a shell with a preassembled locking ring, a liner, and optional screws. The Shells are available in a variety of sizes and are designed to be used with Trilogy Acetabular System liners. The shell implants are used to replace the hip socket during total hip arthroplasty.; ; The device is indicated for primary or revision surgery for rehabilitating hips damaged as a result on noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis,protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis and diastrophic variant. The device is intended for either cemented or noncemented use.
• Code Information: Part 00-6202-052-21, Lot 61132698 and lot 001122467
• Recalling Firm/ Manufacturer: Zimmer Inc.; 345 E Main St; Warsaw IN 46580-2746
• For Additional Information Contact: Cheryl A. Trease; 574-372-4807
• Manufacturer Reason for Recall: Lot # 61132698 and Lot 001122467 (added 9/ 18/2012) may have a manufacturing non conformance that could prevent the devices from functioning as intended. Specifically, devices in the affected lot may have a locking ring groove depth that prevents the corresponding liner from snapping into the shell. The groove provides the locking ring room to displace when inserting a liner into the shell. Th
• FDA Determined Cause: Nonconforming Material/Component
• Action: Zimmer, Inc. sent an "URGENT MEDICAL DEVICE RECALL" letter dated July 27, 2011 to all affected customers of lot 61132698 and 9/18/2012 to only affected customer of lot 001122467. The letters describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to stop using and to quarantine the affected product. An Inventory Return Certification Form was included with the letter for customers to complete and return to Zimmer, Inc. via fax at (574) 372-4265. Replacement product will be provided for all returned product. Contact Zimmer, Inc. at 1-800-613-6131 for questions regarding this recall.
• Quantity in Commerce: 24 devices lot 61132689; 1 device lot 001122467
• Distribution: Worldwide Distribution-USA (nationwide) including the states of CA, NC,NY, PA, WA, and WI and countries of Australia, Germany, The Netherlands, and Switzerland.
• 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 = JDI and Original Applicant = ZIMMER, INC.