Class 2 Device Recall VersaFx Femoral Fixation System

• Date Initiated by Firm: October 11, 2013
• Date Posted: February 20, 2014
• Recall Status: Terminated on April 14, 2017
• Recall Number: Z-1006-2014
• Recall Event ID: 66500
• 510(K)Number: K830196¿(versa
• Product Classification: Appliance, fixation, nail/blade/plate combination, multiple component - Product Code KTT
• Product: VERSA-FX KEYLESS 90D X 8 and X 11, VERSA-FX KEYLESS 95D X 8, X 11, and X 14, VERSA-FX KEYLESS 140D X 4 and X 5, VERSA-FX KEYLESS 135D X 4 and X 5, VERSA-FX SHORT TUBE, 130D, 135D and 140D, VERSA-FX STANDARD TUBE, 1 and VERSA-FX SPRCNDLR TUBE, 9; ; Item codes starting with 001980, 001981, 0011990 and 0011991
• Code Information: 60053473 60528659 60807849 60855076 365855 60807850 60855077 365856 60143351 60384033 60403721 60452546 60543211 60632720 60807851 368913 369123 60219007 60740783 60993433 365857 369559 371074 60539739 60807852 365859 60098398 60119108 60241936 60625494 60082810 60625506 365860 365861 60222477 60109715 60187232 366023 60161891 60116180 60175536 365749 60082811 60109716 60123966 60175537 60231394 60097992 60119110 60123967 60143352 60154511 60165702 60175538 60231395 365740 366424 60109717 60112053 60112054 60116181 60116182 60119111 60119112 60129316 60129317 60154512 60154513 60165703 60175539 60187233 60187234 60206858 60206859 60241934 60161892 365739 60109718 365738 60123968 366024 366025 60136407 365752 365751 60123969 60154514 60082812 60109719 365753 365743 60163222
• 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.