Class 2 Device Recall VerSys Cemented Revision Calcar (CRC) Hip System

• Date Initiated by Firm: August 28, 2013
• Date Posted: November 14, 2013
• Recall Status: Terminated on April 30, 2015
• Recall Number: Z-0277-2014
• Recall Event ID: 66199
• 510(K)Number: K913649 K963109
• Product Classification: Prosthesis, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
• Product: VerSys¿ Cemented Revision Calcar (CRC) Hip System Femoral Stems; VerSys Heritage Hip System Revision Femoral Stems.; ; Indicated for total hip arthroplasty.
• Code Information: 00369673 00369898 00369984 00369985 00369988 00369989 00369995 00369996 00369997 00369998 00370074 00370082 00370103 00370161 00370162 00370163 00370165 00370166 00370240 00370241 00370242 00370244 00370245 00370246 00370285 00370299 00370300 00370301 00370371 00370374 00370376 00370377 00370378 00370379 00370382 00370405 00370406 00370407 00370409 00370411 00370417 00370428 00370471 00370475 00370620 00370621 00370906 60486158 60495799 60495801 60545572 60545573 60545574 60565682 60565683 60589392 60589393 60589394 60609870 60609871 60644570 60644588 60644589 60644590 60658265 60658266 60661955 60661956 60661957 60661958 60661959 60661960 60661962 60661964 60661965 60661966 60661968 60661971 60661974 60676452 60676454 60676455 60676456 60676457 60676459 60676460 60676462 60676463 60676464 60676467 60712462 60712463 60712464 60712465 60712468 60712469 60726764 60737992 60737996 60745879 60745880 60745885 60745886 60745887 60745893 60745898 60768909 60768910 60768911 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• Recalling Firm/ Manufacturer: Zimmer, Inc.; 345 E Main St; Warsaw IN 46580-2746
• For Additional Information Contact: 800-613-6131
• Manufacturer Reason for Recall: Based on a review of historic packaging validations, it was determined that a subset of product packaged in one of the clean rooms at a single Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. The number of samples required for packaging testing (seal integrity and seal strength) to provid
• FDA Determined Cause: Packaging process control
• Action: Removal of the subject devices from the field including distributor and hospital inventories. Distributors and Risk Managers and Surgeons at hospitals that received a direct shipment from Zimmer or its Distributors received a notification on 09/19/2013.
• Quantity in Commerce: 12866 units
• Distribution: Worldwide distribution: US (Nationwide) including Puerto Rico and Virgin Islands; and countries of: Australia, Algeria, Belgium, Bolivia, Canada, Canary Islands, Chile, Croatia, Finland, France, Germany, Greece, Guatemala, Honduras, India, Israel, Italy, Japan, Jordan, Lima-Peru, Malaysia, Morocco, Nicaragua, Portugal, Saudi Arabia, Seoul Korea, Serbia, Singapore, South Africa, Spain, Switzerland, Turkey, Utd.Arab.Emir., United Kingdom, and Venezuela.
• 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.