Class 2 Device Recall Zimmer Segmental System Proximal Femoral Component 38mm Offset, Model Number 00585003038

• Date Initiated by Firm: March 29, 2018
• Create Date: April 16, 2018
• Recall Status: Terminated on December 17, 2019
• Recall Number: Z-1381-2018
• Recall Event ID: 79684
• 510(K)Number: K101296
• Product Classification: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
• Product: Zimmer Segmental System Proximal Femoral Component 38mm Offset, Model Number 00-5850-030-38; ; The Segmental System is used for solving complex salvage cases to address patients with severe bone loss associated with disease, trauma, or revision.
• Code Information: 11002427 11004885 11005449 11006334 11006335 11008928 61369868 61369869 61399454 61399456 61402368 61427788 61427789 61427790 61532231 61532232 61532233 61532234 61532235 61532236 61532237 61532238 61532239 61532241 61551139 61551140 61551141 61636762 61646779 61651745 61673447 61711591 61718216 61730528 61736057 61754485 61765397 61771371 61774299 61853520 61858613 61863256 61863257 61872494 61872495 61877127 61881912 61881913 61886497 61890895 61890896 61890897 61896238 61906572 61932477 61938143 61948661 61948662 61948663 61948664 61948665 61948666 61948667 61948668 61987706 61987707 61993688 61993689 62001043 62001044 62001045 62006906 62006907 62025413 62025414 62025415 62025416 62025417 62032847 62038122 62038123 62050139 62064439 62064441 62068642 62068643 62095951 62118361 62145857 62145858 62145859 62145860 62182529 62182530 62182532 62194346 62194347 62207101 62207102 62207103 62207104 62207105 62207106 62207107 62207108 62212766 62221039 62231040 62241457 62241458 62241459 62269612 62269614 62295471 62295472 62295476 62295478 62295484 62295485 62302621 62304625 62304626 62304629 62304631 62304633 62316980 62356881 62356882 62356883 62359406 62365604 62369067 62369068 62390693 62390695 62390696 62404124 62404134 62404135 62404136 62404137 62442828 62442830 62442831 62448185 62527059 62527060 62532955 62657082 62657084 62657086 62657087 62657088 62657103 62677055 62681448 62681449 62681450 62710734 62722215 62722216 62728198 62738894 62738915 62745181 62751153 62756795 62775210 62775213 62786919 62786920 62786921 62803589 62811462 62811466 62818960 62837956 62837957 62837958 62837959 62837967 62842869 62842872 62850837 62850839 62875912 62876080 62876081 62886654 62886655 62896686 62896689 62905096 62905097 62905289 62916319 62916323 62916325 62916326 62934308 62948025 62948026 62948027 62948028 62968876 62968877 62968878 62968879 63105972 63105973 63137777 63137782 63137783 63157479 63157481 63157484 63157486 63176981 63176982 63183367 63183368 63183369 63204575 63215460 63231604 63231605 63231606 63231607 63240906 63240908 63240909 63240910 63246473 63246475 63253351 63253352 63253447 63253448 63277342 63277343 63277344 63277345 63277346 63277347 63277348 63306196 63309276 63309277 63319777 63326317 63326318 63330467 63330468 63344456 63344457 63369301 63383606 63396702 63396703 63396704 63400314 63400315 63415715 63415716 63415731 63419155 63426584 63426585 63431051 63431052 63431053 63434826 63449965 63449966 63473278 63479267 63479268 63479269 63479270 63521992 63527834 63533207 63538437 63542937 63548851 63548858 63574503 63614078 63614079 63638035 63644371 63651395 63651396 63656914 63656915 63674299 63692535 63698394 63698395 63705470 63705471 63743347 63755766 63760959 63760960 63767677 63781086 63781111 63793354 63793355 63793373 63799812 63799813 63806042 63806043 63806054 63815594 63815607 63837757 63932389 63932391 63932392 61551140R 63246473R 63344456R 63426584R 63434826R 63479270R
• Recalling Firm/ Manufacturer: Zimmer Biomet, Inc.; 1800 W Center St; Warsaw IN 46580-2304
• For Additional Information Contact: 411 Technical Services; 574-371-3071
• Manufacturer Reason for Recall: There is a potential for debris in the hole on the superior lateral aspect of the device as a result of machining which may not have been adequately removed during the subsequent cleaning process.
• FDA Determined Cause: Under Investigation by firm
• Action: Urgent Medical Device Recall letters and emails were distributed on March 29, 2018. Distributors Responsibilities: 1. Review this notification and ensure that affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Immediately return all affected product from your distributorship and from affected hospitals within your territory. a. Complete Attachment 1  Inventory Return Certification Form and send to CorporateQuality.PostMarket@zimmerbiomet.com within three (3) days. b. International distributors can request a International Return Authorization by emailing zimmerbiometintlirarequests@zimmerbiomet.com for returns c. For each return, send a copy of Attachment 1 to CorporateQuality.PostMarket@zimmerbiomet.com. d. Include a hardcopy of Attachment 1 in each carton of your return shipment for immediate processing. e. Mark RECALL on the outside of the returned cartons. 4. Return the Additional Accounts form to CorporateQuality.PostMarket@zimmerbiomet.com. a. Review the list of hospitals and/or surgeons included with the email notification sent to your facility, which includes a list of hospitals and/or surgeons that have already been notified of this recall. b. Identify whether there are any additional hospitals and/or surgeons that Zimmer Biomet has not notified and list these accounts on the Additional Accounts form. Please provide the form in Excel format. c. If there are no additional accounts or surgeons to notify, please indicate that there are no additional accounts, or indicate None or NA on the form. 5. Retain a copy of your Inventory Return Certification and product return forms for your records in the event of a compliance audit of your facility. 6. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating ho
• Quantity in Commerce: 1,145 distribution events. Note that this product is lot controlled and may be distributed multiple times if it was returned and returned to the shelf
• Distribution: Worldwide Distribution - USA (nationwide) to the states of : AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY., and to the countries of : Australia, South Korea, Malaysia, Netherlands, and Singapore.
• 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 = LZO and Original Applicant = ZIMMER, INC.