Class 2 Device Recall LT DISC ULNA HA/PC; RT DISC ULNA HA/PC; LT DISC HMRLHA/PC; RT DISC HMRLHA/PC

• Date Initiated by Firm: August 21, 2019
• Create Date: November 22, 2019
• Recall Status: Terminated on July 21, 2021
• Recall Number: Z-0532-2020
• Recall Event ID: 83783
• Product Classification: Elbow joint metal/polymer, constrained, porous coated, uncemented prosthesis - Product Code PIX
• Product: LT DISC ULNA - HA/PC; RT DISC ULNA - HA/PC;; LT DISC HMRL- HA/PC; RT DISC HMRL- HA/PC;; DISC XS ULNA POR; DISC SEG ULNA POR; and Custom devices; ; ; ; ; Item Nos. 114754; 114755; 114744; 114745; 114704; 114705; 114756; 114757; 114714; 114715; 114746; 114747; 114706; 114707; 114758; 114759; 114716; 114717; 114748; 114749; 114708; 114709; 114718; 114719; CP561429; CP561430; CP561431; CP561432; CP561442; CP561449; CP561488; CP561489; CP561709; CP561710; CP561714; CP561715; PM555203; Product Usage: Total Elbow Replacement
• Code Information: LOTS: 098150 098170 885530 551700 582640 860410 537600 998440 536200 349800 020980 452110 650490 632550 649570 776070 411420 021170 537440 850110 762800 217470 349790 452100 342680 367650 537660 688030 192120 394130 826480 829870 094600 668330 997920 776390 537690 129330 452180 094590 630340 529650 641720 418260 635230 094850 418270 561370 688000 143470 452090 631460 766880 044090 630470 188230 880350 119800 418230 952290 418240 041340 209730 537810 687990 143430 050740 452080 202130 378110 172700 630460 958490 887520 367640 762820 537750 452160 833840 500460 632400 342690 691260 418250 537820 688020 452150 452140 378140 630490 668320 438130 561380 751430 095380 612060 630280 776060 222580 418220 537640 687980 349780 963310 594050 648930 631250 649560 880340 119740 144470 493280 997930 537630 762810 452130 378130 630480 367660 146740 537800 688010 093600 349810 535250 535270 650510 631550 776080 429290 493290 109620 533440 533450 858000 762790 533430 829980 687970 758850 376960 533190 419200 533240 109600 533170 863110 533180 109610 533420 533270 762780 341130 803330 751660 405540 533150 533110 701360 254200 763550 883670 313970 209510 095440 742890 550340 143650 533260 597860 819130 094020 014060 533250 020810 473360 094010 478110 095430 533140 383870 701950 217960 802880 094000 762770 533120 533130 UDI: (01)00880304436343(17)201208(10)650490 (01)00880304436343(17)201208(10)632550 (01)00880304436343(17)210512(10)649570 (01)00880304436343(17)210606(10)776070 (01)00880304436343(17)210824(10)411420 (01)00880304436343(17)220206(10)021170 (01)00880304435964(17)210425(10)342680 (01)00880304435964(17)210812(10)367650 (01)00880304435933(17)210203(10)094600 (01)00880304435933(17)210822(10)668330 (01)00880304435940(17)210203(10)094590 (01)00880304435940(17)201228(10)630340 (01)00880304435940(17)210219(10)529650 (01)00880304435940(17)210219(10)641720 (01)00880304435940(17)210706(10)418260 (01)00880304435940(17)210723(10)635230 (01)00880304435940(17)210907(10)094850 (01)00880304435940(17)211110(10)418270 (01)00880304434295(17)201228(10)631460 (01)00880304434295(17)210122(10)766880 (01)00880304434295(17)210125(10)044090 (01)00880304434295(17)210407(10)630470 (01)00880304434295(17)210416(10)188230 (01)00880304434295(17)210617(10)880350 (01)00880304434295(17)210620(10)119800 (01)00880304434295(17)210820(10)418230 (01)00880304434295(17)210822(10)952290 (01)00880304434295(17)210822(10)418240 (01)00880304434295(17)211110(10)041340 (01)00880304434295(17)211129(10)209730 (01)00880304434837(17)210310(10)378110 (01)00880304434837(17)210407(10)172700 (01)00880304434837(17)210425(10)630460 (01)00880304434837(17)210607(10)958490 (01)00880304434837(17)210607(10)887520 (01)00880304434837(17)210809(10)367640 (01)00880304435957(17)210107(10)632400 (01)00880304435957(17)210607(10)342690 (01)00880304435957(17)210721(10)691260 (01)00880304435957(17)210721(10)418250 (01)00880304434455(17)210210(10)378140 (01)00880304434455(17)210330(10)630490 (01)00880304434455(17)210906(10)668320 (01)00880304434332(17)201204(10)630280 (01)00880304434332(17)210812(10)776060 (01)00880304434332(17)210906(10)222580 (01)00880304434332(17)210912(10)418220 (01)00880304435056(17)201204(10)648930 (01)00880304435056(17)201204(10)631250 (01)00880304435056(17)210520(10)649560 (01)00880304435056(17)210608(10)880340 (01)00880304435056(17)210621(10)119740 (01)00880304435056(17)210901(10)144470 (01)00880304435056(17)221029(10)493280 (01)00880304436008(17)210210(10)378130 (01)00880304436008(17)210315(10)630480 (01)00880304436008(17)210830(10)367660 (01)00880304436008(17)210906(10)146740 (01)00880304434448(17)201209(10)650510 (01)00880304434448(17)201228(10)631550 (01)00880304434448(17)210607(10)776080 (01)00880304434448(17)210707(10)429290 (01)00880304434448(17)230221(10)493290 (01)00880304435971(17)250911(10)819130 (01)00880304435971(17)260728(10)094020 (01)00880304434387(17)251211(10)473360 (01)00880304434387(17)261101(10)094010 (01)00880304437500(17)260714(10)802880 (01)00880304437500(17)260720(10)094000
• Recalling Firm/ Manufacturer: Zimmer Biomet, Inc.; 56 E Bell Dr; Warsaw IN 46582-6989
• For Additional Information Contact: 411 Technical Services; 574-371-3071
• Manufacturer Reason for Recall: Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
• FDA Determined Cause: Environmental control
• Action: On September 11, 2019, the firm began notifying distributors and customers of the recall via an Urgent Medical Device Recall letter. The letter informed consignees of the product issue. Customers were asked to assist their Zimmer Biomet sales representative and quarantine all identified product. The sales representative will remove the product from your facility. If any products were further distributed, please forward the notification to responsible parties. If you have further questions or concerns, please call customer service at 574-371-3071 between 8:00 am and 5:00 pm ET, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com. There are no specific patient monitoring instructions related to this recall that are recommended beyond your existing follow-up schedule.
• Quantity in Commerce: 217240
• Distribution: US Nationwide distribution and countries of Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecuador, El Salvador, Italy, Netherlands, India, Japan, Korea, Malaysia, Mexico, New Zealand, Panama, Singapore, Taiwan, Thailand, Trinidad and Tobago, 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.