BALL NOSE GUIDE WIRE 80CM, 100CM. Item Nos. 281001080 281001100 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 Ball Nose Guide Wire devices in 80cm and 100cm lengths (item numbers 281001080 and 281001100) distributed nationwide in the United States and internationally across 22 other countries. A total of 1,729 units are affected across numerous lot codes. The devices are used to facilitate the implantation of orthopedic medical devices.
The recall was initiated because elevated levels of bacterial endotoxin and residual debris were found on the devices due to a cleaning issue during manufacturing. The recall record does not specify a remedy for affected consumers.
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: 1729 Lot/code info: LOTS: 396280 630880 705620 705640 666290 705650 084760 222820 222830 222840 222850 222860 222880 222890 222900 222910 222920 222930 222940 103057 103058 103059 103061 103062 103063 103064 106566 106567 117023 117024 117026 117027 117028 117029 117030 117032 117033 117033R 117034 135911 135912 135913 135914 135915 135916 135917 135918 164597 164598 164606 164607 164611 164612 206297 206298 206299 206300 206301 206302 206303 206304 206305 206306 206307 206308 206309 244980 244981 244982 244983 244983R 244984 244984R 244985 244988 244989 244992 244993 260818 260819 270168 270169 270170 270171 270172 270173 270174 303127 303128 303129 303130 303131 306089 306090 306091 306092 405640 764611 A38AE7 B3TAB7 B3TAC7 B3VAC7 B3VAE7 B78AA7 BX2AA7 BX2AF7 BX2AG7 BX2AJ7 BX2AJ728 BX2AK7 C14AC7 C14AE7 C3AAC7 C3AAD7 C3AAG7 C3AAH7 C3AAK7 C74AA7 C74AB7 C74AD7 CH2AA7 CH2AA720 CH7AA7 CH7AB7 CW3AK7 CW3AL7 CX8AD7 D1HAA7 D1HAB7 D1HAC7 D1HAD7 DA9AA7 DA9AB7 DA9AB7R DA9AC7 DD6AA7 DG8AA7 DG8AC7 DG8AD7 DN5AB7 DN5AC7 DR8AA7 DR8AC7 DR8AD7 DV9AA7 DV9AB DV9AB7 DV9AC7 DV9AD7 E19AA7 E19AC7 E19AD7 E19AE7 E19AF7 E3SAH7 E3SAJ7 E3SAK7 E3SAL7 E3SAM7 E3SAN7 E3SAP7 E3SAR7 EK2AB7 EK2AD7 EK2AE7 EK2AF7 EK2AG7 EK2AH7 EK2AK7 EK2AL7 EK2AN7 EK2AP7 EK2AR7 NZV710Q Y5XAD7000 Y5XAE7 YX8AP7000 YX8AW7 ZC6A17 ZC6AR7000 259950 630770 830520 666230 396300 705610 538950 199980 199990 220100 220180 220250 106569 106570 106571 106572 106573 106574 106575 106576 106577 106578 106579 106580 106581 106582 106583 106584 106585 108579 117035
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.