Biomet, Inc.: Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may lead to an infection.

Agency Publication Date: May 26, 2016

Affected Products

Product: Various trauma and sports medicine instruments and implants. guide, surgical, instrument

Part #'s 281001080 281001100 35-351208 35-351534 35-351564 Lot #'s 606200 606210 606220 614280 661690 661700 661660 755290 764390 764400 621850

Product: Various trauma and sports medicine instruments and implants. cannula, surgical, general & plastic surgery and accessories

Part #'s 900360 900364 900360H 900360HI 900363H 900364I Lot #'s 606770 343280 420090 742780 763750 742780 565910 343280

Product: Various trauma and sports medicine instruments and implants. Plate, fixation, bone.

Part #'s 24616 131212112 131212113 131212114 131212116 131212118 131212216 131212218 131212220 131212222 131212224 131212316 131212318 131212320 131212322 856135016 856135018 856135020 856135022 856135024 856135026 856135028 856135030 856135034 856135036 856135038 856135040 856135042 Lot #'s 606160 729130 664900 752650 752660 664910 664930 752680 664950 752690 752720 664990 665020 665040 665060 665070 665090 665100 665120 665130 758430 758500 758520 758540 758550 758570 758670 758680 758700 758710 758720 758730 758740

Product: Various trauma and sports medicine instruments and implants. Arthroscope.

Part #'s 908518 908520 Lot #'s 675890 579290 579300

Product: Various trauma and sports medicine instruments and implants. Rod, fixation, intramedullary and accessories.

Part #'s 28234 28338 28811 28813 28821 29260 29822 805065080 14-400428 14-400436 14-405032 14-405040 14-440118 14-440121 14-441280 14-440066S Lot #'s 590970 591080 591090 665210 692040 692250 692280 692290 695900 610470 665230 665240 692440 692450 692480 692620 692660 692670 692690 721680 721720 721730 729080 722730 621840 621860 678300 664740 664820 664870 664880 503760 503770 693840 476230

Product: Various trauma and sports medicine instruments and implants. Reamer.

Part #'s 41009 110004188 110010579 Lot #'s 668490 756990 757010 757030 758180

Product: Various trauma and sports medicine instruments and implants. Bit, drill.

Part #'s 24445 27961 904301 904760 231201307 Lot #'s 693880 606180 614250 668360 625470 710630 710640 668330

Product: Various trauma and sports medicine instruments and implants. Pin, fixation, smooth.

Part #'s 24415 24416 27914 27922 328010 14-401440 14-450360 14-450365 14-450380 14-450390 35-361681 Lot #'s 679900 693860 729090 722660 668350 591000 591010 591020 652700 745110 752860 728860 652650 664410 664440 606280

Product: Various trauma and sports medicine instruments and implants. Screw, fixation, bone.

Part #'s HAA60-11030 HAA60-13030 HAA60-15040 HAA60-16040 HAA60-18040 Lot #'s 016150 016210 165130 016230 133890 181600 133970 134000 181620

Product: Various trauma and sports medicine instruments and implants. Passer.

Part #'s 904051 Lot #'s 880370 673790

Product: Various trauma and sports medicine instruments and implants. Appliance, fixation, nail/blade/plate combination, multiple component.

Part #'s 200185 200195 200200 16-235136 Lot #'s 711680 655630 691980 722690 692000 722670 744670

Product: Various trauma and sports medicine instruments and implants. Spinal interlaminal fixation orthosis.

Part #'s 904756 Lot #'s 625590

Product: Various trauma and sports medicine instruments and implants. Orthopedic manual surgical instrument.

Part #'s 900728 900737 900738 900740 909836 110008343 110009769 231201303 Lot #'s 669220 625160 625180 679060 529190 585920 742460 751280 751290 751330 751400 751410 751420 751430 630570

Product: Various trauma and sports medicine instruments and implants. Fastener, fixation, nondegradable, soft tissue.

Part #'s 904414 904723 904727 904754 904755 904781 904834 912029 912030 912031 912037 912046 912050 912057 912068 912069 912071 912073 912076 912077 912082 912091 916036 110003172 110003182 110005093 110005096 110005198 110005306 110005307 110016992 912036R 912036R 912037R 912040R 912141C Lot #'s 625480 673840 763780 652380 652400 652420 652430 652440 656180 607100 563710 563720 625660 654830 654850 654870 649000 649010 649030 649040 649050 649060 649070 649080 649100 654420 654480 654490 654500 654590 654600 654610 654680 676910 676920 676930 677020 655030 530920 579450 579460 579480 579490 579500 579510 579520 579530 579540 649150 649160 655050 655100 677120 677130 677150 677160 677170 677180 649880 649930 649960 649990 677340 650010 650050 628350 677980 657260 657280 657290 722500 649490 649520 649550 649580 649600 649620 649630 655160 649830 649850 678220 678230 678260 678280 655220 664610 676800 676810 676940 676950 677480

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 74038

Status: Resolved

Manufacturer: Biomet, Inc.

Manufactured In: United States

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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Affected Products