Biomet, Inc. recalls Zimmer Biomet Comprehensive Segmental Revision System (SRS).

Hazard / Issue

During assembly, an SRS Humeral Distal Body implant failed to engage correctly at the point of reduction with a Discovery Elbow System Humeral Condyle. A mismatch between the screw holes in the Humeral Body & Elbow Condyle affects assembly during surgery. If the product has already been implanted, no action is required. The mismatch is estimated to prevent screw engagement in less than 1% of cases.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: Model numbers: 211250 211251 211252 211253 211254 211255 Lot codes: 095580 119120 130020 142530 155910 162450 162460 241160 257860 304290 305860 309730 337610 389790 400730 419380 430570 443670 545430 546260 548290 550390 586120 606830 611540 636370 636470 688540 704020 714760 793670 806070 829520 829530 881230 950270 970920 019600 110780 130040 157180 185620 203520 241180 278580 330870 364380 424550 430580 457210 544340 583360 636520 706690 714810 810260 853250 881330 883830 891880 923660 923680 991400 033700 053800 062210 110790 160770 185630 241190 247810 257870 347080 583370 611530 636680 638640 674650 688550 775020 829540 848530 889330 950310 976390 988380 991410 028450 028460 053810 062220 098020 155900 160780 231490 241230 251120 251920 257880 281140 330880 347100 367850 400390 450780 493220 494170 527200 546290 548460 548470 548580 586130 611520 636710 665880 704030 761210 829550 853260 889810 914750 923670 923690 925920 927420 937130 991320 062830 119130 130070 185590 196660 201270 241290 247280 247290 257890 338480 347110 350590 366310 554450 636760 648150 704040 714830 750840 767880 793710 829560 878430 927430 948090 952960 970930 976410 040470 192770 241300 258540 288580 293740 320100 340150 347700 364660 419900 442840 462480 462490 569770 611040 611930 688560 770690 780490 815100 818160 829690 867530 891270 923980 924160 927440 201270 848530 976410 033700 350590 554450 ***Lots added 3/31/2020*** Item Number 211253 - Lot Number 434480 - UDI (1)00880304850330(17)280423(10)434480 Item Number 211251 - Lot Number 434470 - UDI (1)00880304850316(17)280507(10)434470