medical Class II Updated 2019-12-04

Zimmer Biomet, Inc. recalls LT DISC ULNA - HA/PC; RT DISC ULNA - HA/PC; LT DISC HMRL- H

Recalled 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

Hazard / Issue

Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 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
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