Zimmer Biomet, Inc. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Zimmer Biomet, Inc.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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 117036 117037 117038 135048 135642 135924 135925 135926 135928 135929 135931 135932 135934 135935 135938 135939 135941 135942 135945 135946 135947 135948 164635 164636 164642 164643 164645 164646 164652 164653 184636 206314 206315 245001 245002 245003 245004 245005 245006 260802 260803 260804 260805 260806 260807 260808 260809 260811 260812 260813 260814 260816 303132 303133 306093 306094 306098 306099 306100 306101 A18AA7 A38AF7 A45AD7 AD7AD7 AD7AF7 AR5AC7 AT9AJ7 AV9AB7 AV9AD7 AV9AJ7 B2RAC7 B2RAD7 B2RAF7 B2RAG7 B2RAH7 B2RAJ7 B2RAL7 B78AD7 C14AH7 C3AAL7 C3AAN7 C3AAP7 C3AAR7 C3AAS7 C3AAV7 CD2AC7 CD2AD7 CH1AD7 CH1AF7 CN8AD7 CW3AP7 CW3AR7 CW3AS7 CX8AF7 CX8AG7 D1HAE7 D1HAF7 D1HAG7 D1HAH7 DA9AE7 DA9AF7 DA9AG7 DA9AH7 DD6AE7 DD6AG7 DN5AF7 DN5AG7 DN5AH7 DN5AH7R DR8AE7 DR8AF7 DR8AF7R DR8AG7 DR8AH7 E19AG7 E19AH7 E19AH7R E3SAD7 E3SAF7 E3SAFA E3SAG7 EC9AA7 EC9AB7 EC9AC7 EC9AD7 EC9AE7 EC9AF7 EK2A17 EK2A27 EK2A37 EK2A47 EK2A57 EK2A67 EK2A67D EK2A77 EK2A87 EK2AA7 EK2AS7 EK2AT7 EK2AV7 EK2AW7 EK2AX7 EK2AY7 EW1AA7 FA4AK7A NXV7113R Y5XAP7000 ZV8AE7 UDI: (01)00887868027857(17)231009(10)396280 (01)00887868027864(17)231016(10)830520
Zimmer Biomet, Inc. is recalling BALL NOSE GUIDE WIRE 80CM, 100CM. Item Nos. 281001080 281001100 Product Usage: These instruments due to Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Recommended Action
Per FDA guidance
On September 11, 2019, the firm began notifying distributors and customers of the recall via an Urgent Medical Device Recall letter. The letter informed consignees of the product issue. Customers were asked to assist their Zimmer Biomet sales representative and quarantine all identified product. The sales representative will remove the product from your facility. If any products were further distributed, please forward the notification to responsible parties. If you have further questions or concerns, please call customer service at 574-371-3071 between 8:00 am and 5:00 pm ET, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com. There are no specific patient monitoring instructions related to this recall that are recommended beyond your existing follow-up schedule.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026