FDAFDA · Food and drugs·Recall number Z-0528-2020
HA Pins (DFS HA Cort Screw), Hoffman/Colles Pins (Colles CSER Sterile w/ Pin Kit) Item Nos: HAA60-09030 HAA60-09040 HAA60-10030 HAA60-10040 HAA60-11030 HAA60-11040 HAA60-11050 HAA60-12040 HAA60-12060 HAA60-13030 HAA60-13040 HAA60-13050 HAA60-13060 HAA60-13070 HAA60-14050 HAA60-14080 HAA60-14090 HAA60-15020 HAA60-15030 HAA60-15040 HAA60-15050 HAA60-15060 HAA60-16030 HAA60-16040 HAA60-16050 HAA60-16070 HAA60-16090 HAA60-17040 HAA60-17060 HAA60-17080 HAA60-18010 HAA60-18030 HAA60-18040 HAA60-18050 HAA60-18060 HAA60-18090 HAA60-20030 HAA60-20040 HAA60-20050 HAA60-20060 HAA60-20080 HAA60-20090 HAA60-22050 HAA60-22060 HAA60-25030 HAA60-25040 HAA60-25050 HAA60-25060 HAA60-30060 HAB60-09030 HAB60-10030 HAB60-10040 HAB60-11040 HAB60-11050 HAB60-12040 HAB60-12060 HAB60-13040 HAB60-13050 HAB60-13060 HAB60-14050 HAB60-15060 HAB60-16070 HAB60-16090 HAB60-17080 HAB60-18010 HAB60-18090 HAB60-20080 HAB60-20090 808200000 Product Usage: These devices are intended for osteosynthesis, external fixation of fractures or bone lengthening procedures.
Published December 4, 2019 · Recall initiated: August 21, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Zimmer Biomet, Inc.
- Distributor
- 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.
- Lot
- Lots 089610 241030 089600 241020 238180 416260 507280 450740 314580 736790 779690 889140 836030 970200 444550 984630 316530 198990 419500 431591 444655 459030 633280 921380 148200 441530 718410 884690 856150 444530 066610 352090 553250 HA109-05 148190 666010 825420 989490R 989490 444510 444510R 984610 241410 390410 152390 316520 390410R 432706 484710 484720 238170 427280 450730 323210 507270 748450 789870 877610 002130 444500 984600 363080 670430 136700 198960 198970 230290 230300 413443 413444 432705 984600R 148180 441520 456560 732840 825410 889130 970190 444420 984580 921390 530950 120230 198910 198930 230280 413441 803810 803810R 086800 357830 740750 921550 450720 323200 640280 718400 856140 946100 444470 057550 386080 303010 633210 403720 516120 418870 824120 592130 148930 017430 802520 274630 966250 966260 047790 351330 822190 846490 131420 131430 912600 965370 277220 314570 450710 771080 856130R 856130 988850 251590 444450 621070 147070 530940 120220 198850 341593 419499 422450 450710R 633250 831320 089680 340980 241400 118720 441510 516910 771070 836020 835980 444140 066600 120210 198820 436780 697210 722780 238160 375410 375410R 344370 441500 456550 825400 831310 884680 924720 946090 989480 242060 444120 984570 524230 524230R 559330 628180 017420 110510 139030 198790 230260 230270 349160 428342 428608 432704 553220 553230 553240 671740 671750 803800 237530 541190 427240 740740 064900 003150 314520 148170 456540 338850 507260 547070 659870 630650 775690 889120 779680 804350 856120 946080 970180 002120 004740 251580 444100 007640 333720 449860 102550 194590 194600 237250 418830 774130 110710 273080 638390 141600 950170 950130 484730 484680 524220 621770 785560 210030 714850 717010 966230 717130 152420 002370 949680 949690 068340 120400 131400 131410 230310 230320 2375300 341591 349159 418581 432702 439398 619620 799540 921370 237520 427220 826470 118710 328020 405050 450700 483680 547060 640270 713900 856110 789860 889110 889100 989470 004730 242050 251570 444090 984560 621060 843670 956170 956030 956130 877470 723170 152380 921380 139020 230200 341590 349158 435195 619610 637560 671570 768780 799530 912580 140590 425870 826460 198330 323190 450690 465770 483660 483670 604030 836010 889090 877600 779670 946070 979720 033500 444070 444070R 984550 374440 867190 516050 921370 126090 732750 029130 771190 360100 392660 598350 152370 002340 966220 970150 821360 949660 949670 139010 198740 230190 410785 419769 440610 637540 671720 089670 241390 671460 740730 064890 921440 921540 198320 328010 284830 298720 231090 428460 395330 421200 441490 456530 544180 547050 465750 465760 500530 513090 604020 500540 601650 607620 624020 649280 630640 684560R 684560 718390 856100 889080 979710 930710 002110 320780 251560 444060 984540 057530 092160 241380 590720 241370 492090 403710 670420 732710 536860 580250 592100 592090 459910 154350 017410 877450 360080 717000 966210 316480 092160R 341588 386580 388258 418573 435193 435194 634920 634930 634970 634990 635030 722770 817050 100430 541100 712020 148160 003020 416250 314500 338840 284820 375400 441480 465740 513080 596390 684550 630630 718380 659860 771060 979700 856090 002100 946060 070080 251550 444010 444050 984530 057520 102540 473360 516040 921360 931580 459900 950060 524210 459500 134030 766440 559120 672750 970140 316460 821350 949650 103150 139000 198690 230140 230150 321830 350841 352080 414693 440550 513080R 671700 737280 799520 866015 921430 921420 064880 231050 198300 630610 700100 624010 649
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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