FDA Device recall Z-0530-2020
BALL NOSE GUIDE WIRE 80CM, 100CM. Item Nos. 281001080 281001100 Product Usage: These instruments and delivery systems are used to facilitat…
- FDA Device
- Class II
- terminated
- Published 2019-12-04
On 2019-12-04 the FDA classified a Class II recall of BALL NOSE GUIDE WIRE 80CM, 100CM. Item Nos. 281001080 281001100 Product Usage: These instruments and delivery systems are used to facilitat… by Zimmer Biomet, citing elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0530-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-08-21 |
| Published | 2019-12-04 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Zimmer Biomet |
| Distribution | US |
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.
Reason
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Identifiers
| code_info | LOTS: 396280 630880 705620 705640 666290 705650 084760 222820 222830 222840 222850 222860 222880 222890 2…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 CH7 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0530-2020%22
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