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 HAA6
Check against the official notice below — it lists the full affected range.
Zimmer Biomet, Inc. is recalling HA Pins (DFS HA Cort Screw) and Hoffman/Colles Pins (Colles CSER Sterile w/ Pin Kit) due to elevated levels of bacterial endotoxin and residual debris remaining on the devices caused by a cleaning issue. The recalled devices were distributed nationwide in the United States and internationally to 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. Approximately 178,886 units are affected across numerous lot codes.
The source document does not specify a remedy or instructions for what affected consumers should do regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Reason for recall: Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. 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. Quantity: 178886 Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.