Class 2 Device Recall VerSys Heritage

• Date Initiated by Firm: October 11, 2013
• Date Posted: February 20, 2014
• Recall Status: Terminated on April 14, 2017
• Recall Number: Z-1028-2014
• Recall Event ID: 66500
• PMA Number: P040048
• Product Classification: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented - Product Code MRA
• Product: VERSYS HERITAGE FEM STEM
• Code Information: 60888636 60953044 60953045 60990022 60990023 61037925 61101347 61190038 61199991 61216692 61231958 61337105 61337106 61337108 61337109 61380551 61393846 61395480 61395481 61395482 61457789 61488608 61501472 61528642 61607607 61613260 61631108 61636270 61640544 61658343 61727080 61795011 61803866 61830030 61841636 61841637 61859438 61860472 61878469 61880368 61903233 61936199 61980174 62001339 62024623 62055989 62055991 62097061 62106808 62143853 62147329 62147330 62199398 62199399 62213245 62232590 62240777 62257146 62268582 62268583 62281833 62298293 62305944 369871 61282966 61727082 61962092 369672 61189806 61266267 61294351 369898 61293625
• Recalling Firm/ Manufacturer: Zimmer, Inc.; 345 E Main St; Warsaw IN 46580-2746
• For Additional Information Contact: 800-613-6131
• Manufacturer Reason for Recall: Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.
• FDA Determined Cause: Packaging
• Action: Distributors received a letter identifying the issue and their responsibilities dated November 4, 2013. These responsibilities include quarantining the affected fielded inventory in their possession, providing hospital risk managers with the recall notification letter and retrieving affected fielded inventory and direct sales from the hospitals.
• Quantity in Commerce: 7,044,680 total
• Distribution: Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.
• 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.

• PMA Database: PMAs with Product Code = MRA and Original Applicant = ZIMMER, INC.