2.0MM BALL NOSE GUIDE WIRE, Item Nos. 281017006 - Product Usage: These instruments and delivery systems are used to facilitate implantation of orthopedic medical devices.
Check against the official notice below — it lists the full affected range.
Zimmer Biomet, Inc. is recalling 2,708 units of 2.0MM Ball Nose Guide Wire (Item No. 281017006) distributed nationwide in the United States and internationally to multiple countries. These instruments are used to help implant orthopedic medical devices. The devices are being recalled because elevated levels of bacterial endotoxin and residual debris remain on them due to a cleaning issue during manufacturing.
The affected products include multiple lot numbers and codes listed in the recall notice. The source document does not specify what remedy is available to consumers who may have received or used these devices.
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: 2708 Lot/code info: LOTS: 206322 062980 062690 062720 062740 062760 062950 062960 062970 730390 730400 730380 158530 158510 158520 460220 859610 860250 661640 977840 977850 114600 167450 204150 204160 204180 204190 204200 204210 678430 491410 678420 233730 233770 392590 233710 233720 694090 039330 039340 039350 039360 039370 039380 039450 039420 039390 039400 039410 039430 039440 039460 039470 113340 994740 036320 036330 665740 994730 036290 204970 204990 205000 205010 205020 472130 164579 164582 164586 164587 206318 206319 206320 206321 260820 260821 270166 270167 AF6AE7000 AT9AG7 B5KAT7 B5LAA7 B78AE7 B78AF7 BD3AA7 BT9AD7 BX2AB7 CN8AG7 CN8AH7 CW3AT7 CW3AV7 CW3AV7R CW3AW7 CW3AW7R CW3AX7 E3SAB7 E3SAC7 EG9AF7 EG9AG7 EG9AH7 EG9AJ7 NXW351U NXW351V UDI: (01)00887868029448(17)220501(10)206322 (01)00887868029448(17)240819(10)062980 (01)00887868029448(17)240819(10)062690 (01)00887868029448(17)240819(10)062720 (01)00887868029448(17)240819(10)062740 (01)00887868029448(17)240819(10)062760 (01)00887868029448(17)240819(10)062950 (01)00887868029448(17)240819(10)062960 (01)00887868029448(17)240819(10)062970 (01)00887868029448(17)241013(10)730390 (01)00887868029448(17)241013(10)730400 (01)00887868029448(17)241013(10)730380 (01)00887868029448(17)241101(10)158530 (01)00887868029448(17)241103(10)158510 (01)00887868029448(17)241103(10)158520 (01)00887868029448(17)241201(10)460220 (01)00887868029448(17)250115(10)859610 (01)00887868029448(17)250116(10)860250 (01)00887868029448(17)250410(10)661640 (01)00887868029448(1
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.