Class 2 Device Recall Free Lock Femoral Fixation System

• Date Initiated by Firm: June 19, 2013
• Date Posted: August 26, 2013
• Recall Status: Terminated on June 16, 2015
• Recall Number: Z-2091-2013
• Recall Event ID: 65513
• 510(K)Number: K830196
• Product Classification: Appliance, fixation, nail/blade/plate combination, multiple component - Product Code KTT
• Product: Free Lock Femoral Hip Fixation System Compression Tube/Plate, different length (59, 75, 91, 107, 123 mm), holes (2, 3, 4, 5, 6) and degree angles (130, 135, 140, 145 and 150). Item codes starting with 00-1181-130, 00-1181-135, 00-1181-140, 00-1181-145, 00-1181-150). ; ; ZIMMER Compression Hip Screw , orthopedic implant.
• Code Information: 60611049 60624520 60619105 60619109 60624518 60624519 60625544 60619107 60619879 60611045 60624521 60625511 60625536 60625542 60582204 60619887 60657047 60646266 60657046 60657070 60657071 60657072 60632725 60657051 60657073 60657083 60657075 60657078 60657088 60625545 60646267 60657049 60657052 60657077 60657079 60657087 60657084 60668304 60668305 60582089 60674430 60674431 60685115 60714886 60714872 60714893 60714875 60714897 60714851 60714890 60714892 60714850 60714877 60714896 60714891 60714894 60763218 60763232 60763219 60763220 60763221 60763226 60763230 60763234 60763223 60763227 60763229 60763222 60763224 60763225 60763231 60763233 60714895 60763228 60803587 60803589 60803591 60803592 60803593 60807853 60807854 60803588 60803590 60807855 60803586 60807868 60815019 60820809 60841203 60820796 60807857 60820798 60820801 60807858 60807859 60807861 60807856 60815017 60807865 60820810 60820807 60868474 60868478 60874089 60874093 60874097 60877491 60868477 60885177 60885178 60885180 60885182 60885175 60885179 60885185 60885184 60902841 60905697 60902842 60902843 60911345 60911346 60911348 60911350 60931165 60931166 60911349 60931164 60938423 60944574 60931167 60931168 60944606 60932394 60944525 60938427 60944551 60968742 60959978 60969382 60972805 60972806 60968739 60968744 60988403 60988405 60962160 60988402 60988407 60988408 60988404 60998291 60998292 61020344 61030741 61020343 61030740 61037492 61030742 61037493 61037494 61048120 61048117 61048116 61048119 61048115 61048121 61027553 61048118 61027552 61076085 61076086 61086854 61086857 61079836 61079834 61092273 61092280 61101553 61092247 61092249 61092258 61092281 61092283 61101552 61101554 61103203 61103208 61101551 61103202 61103204 61103206 61103207 61108242 61108243 61108244 61115872 61114143 61118976 61140178 61162614 61162616 61162617 61162615 61169420 61198462 61264756 61269944 61198455 61162618 61179754 61179757 61198458 61198460 61198461 61209574 61198456 61209572 61209573 61198457 61264754 61269949 61264753 61198459 61286925 61288126 61294831 61246085 61264748 61286923 61286928 61294832 61294833 61304496 61264749 61264750 61286930 61326116 61264752 61264751 61294834 61341158 61352935 61294835 61352934 61352936 61359996 61359995 61359994 61420344 61420343 61412173 61375175 61436467 61377328 61377330 61379892 61402004 61402005 61402007 61440257 61440688 61375177 61437988 61440689 61457772 61379890 61379891 61437989 61463554 61463555 61440690 61453112 61464380 61457773 61464381 61453111 61463557 61464379 61408293 61473803 61512406 61523582 61523859 61529230 61538716 61542608 61542610 61542611 61558660 61558661 61565485 61565484 61565488 61565486 61565487 61565489 61585377 61578712 61584969 61590989 61590993 61590994 61602063 61613172 61602064 61621833 61628735 61621843 61635176 61621834 61621838 61621842 61640885 61640886 61640887 61700444 61682532 61682545 61672121 61682542 61682544 61682546 61717286 61714071 61719312 61746531 61719308 61719314 61752596 61752594 61752599 61752602 61753041 61761524 61682547 61753042 61753043 61756193 61853082 61870425 61888704 61902191 61990140 62271890 62271887
• Recalling Firm/ Manufacturer: Zimmer, Inc.; 345 E Main St; Warsaw IN 46580-2746
• For Additional Information Contact: Questions and Concerns Number; 877-946-2761
• Manufacturer Reason for Recall: Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak test compromising the sterility of the product.
• FDA Determined Cause: Packaging process control
• Action: The firm, Zimmer, sent an "URGENT MEDICAL DEVICE NOTIFICATION" letter dated July 11, 2013 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to inspect the device according to the insert instructions; not use the device if damage to the corner of the inner tray is observed, and contact the firm for return and questions. Customers should also keep this notification in mind and inform Zimmer of product with this condition using zimmer.per@zimmer.com. If after reviewing this notification you have questions or concerns, please contact Zimmer at 1-877-946-2761.
• Quantity in Commerce: 85, 794 units in total
• Distribution: Worldwide distribution: US Nationwide (including PR and USVI), and countries of: Israel, Argentina, Brazil, France, Mexico, Saudi Arabia, Beirut, China, Korea, San Salvador, Honduras, Canada, Australia, Switzerland, Germany, Arab Emirates, UK, Belgium, Egypt, Spain, France, Italy, Iran, Lebanon, Jordan, Iraq, Canary Islands.
• 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 = KTT and Original Applicant = ZIMMER, INC.