Class 2 Device Recall Continuum Hip Cups

• Date Initiated by Firm: October 01, 2014
• Date Posted: October 20, 2014
• Recall Status: Terminated on March 02, 2015
• Recall Number: Z-0094-2015
• Recall Event ID: 69301
• 510(K)Number: K091508
• Product Classification: Prosthesis, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
• Product: Continuum Acetabular System Trabecular Metal Shell with Multi Holes, Porous 68mm, Prosthesis, Hip, Semi-Constrained, Metal/Polymer
• Code Information: Part Number: 00-8757-068-02; Lot Number: 62207029
• Recalling Firm/ Manufacturer: Zimmer, Inc.; 1800 W Center St; Warsaw IN 46580-2304
• For Additional Information Contact: 800-613-6131
• Manufacturer Reason for Recall: The affected products are missing polar boss threads.
• FDA Determined Cause: Equipment maintenance
• Action: Zimmer sent an "URGENT MEDICAL DEVICE RECALL- LOT SPECIFIC" notifications dated October 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Your Responsibilities 1. Review the notification and ensure affected personnel are aware of the contents. 2. If you find any product from the affected lot , quarantine the product and notify your Zimmer sales representative. 3. Your Zimmer sales representative will remove the recalled product from your facility. 4. For patients that previously had this product implanted, it is recommended that you continue your normal post operative follow up routine. 5. If after reviewing this notification you have further questions or concerns please call the customer call center at 1-800-348-2759 between 8:00 am and 5:00pm EST.
• Quantity in Commerce: 19
• Distribution: Worldwide Distribution: US (nationwide) in the states of : IA, CA, NC, AL, WA, FL, TN, MA, AZ, TX, UT, and NV; and Internationally to Japan.
• 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