Class 2 Device Recall Zimmer Trabecular metal Modular Acetabular system

• Date Initiated by Firm: August 18, 2010
• Date Posted: October 14, 2010
• Recall Status: Terminated on February 07, 2011
• Recall Number: Z-0060-2011
• Recall Event ID: 56651
• 510(K)Number: K021891
• Product Classification: prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
• Product: Zimmer Trabecular metal Modular Acetabular system 56 mm Porous shell with cluster holes, Catalog 00-6202-056-22, Zimmer Inc., Warsaw, IN. This device is indicated for primary or revision surgery for rehabilitating hips damaged as the result of noninflammatory degenerative joint disease, including osteoarthritis, fused hip, avascular necrosis, traumatic arthritis and fracture of the pelvis.
• Code Information: 61091653
• Recalling Firm/ Manufacturer: Zimmer Inc.; 1800 W Center St; Warsaw IN 46580-2304
• For Additional Information Contact: 574-267-6131
• Manufacturer Reason for Recall: The threads on the device were not completely machined and therefore would not mate with athe corresponding cup positioner/shell inserter.
• FDA Determined Cause: Other
• Action: The firm, Zimmer, made telephone calls using a phone script document entitled "Urgent: Medical Device Recall" Phone Script Call Communication, to the customers that received this product starting on 8/18/2010. The telephone calls were to determine the status of the recalled product. A Zimmer Field Action Strategy notification dated August 9, 2010 was also provided. The notifications/phone script described the product, problem and actions to be taken by the customers. The customers were instructed to remove the 00-6202-056-22, lot 61091653 product from their inventory and return to Zimmer Product Service Department, Attn: Product Service, 1777 West Center Street, Warsaw, IN 45680. Note: If the product had been used, no action was necessary. The returned product will be evaluated to determine how many of the devices had the defect. If you have any questions, please call (574) 371-8852.
• Quantity in Commerce: 24
• Distribution: Worldwide distribution:USA including states of: MI, IN, WI, MO, CA, VA, MD, TX, NC, PA, OR, WA, FL, GA, NY, ME, AZ, and UT and country including Canada.
• 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 = LPH