FDA Device recall Z-0520-2021
Yukon OCT Spinal System Yukon Anti-Torque Alignment Tube - Product Usage: The Anti-Torque Alignment Tube (the Alignment Tube ) provides cou…
- FDA Device
- Class II
- terminated
- Published 2020-12-09
On 2020-12-09 the FDA classified a Class II recall of Yukon OCT Spinal System Yukon Anti-Torque Alignment Tube - Product Usage: The Anti-Torque Alignment Tube (the Alignment Tube ) provides cou… by K2m, citing shafts do not pass through the inner cannula of the Anti-Torque Alignment Tube from Lot KTGG due to a manufacturing nonconformance. This could result in a delay of surgery or resu….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0520-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-11-03 |
| Published | 2020-12-09 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | K2m |
| Distribution | US |
Product
Yukon OCT Spinal System Yukon Anti-Torque Alignment Tube - Product Usage: The Anti-Torque Alignment Tube (the Alignment Tube ) provides counter rotation to reduce the torque applied to the anatomy when the size 15 Torque limiting shaft (the shaft is used to tighten the Yukon Set Screw to the specified torque.
Reason
Shafts do not pass through the inner cannula of the Anti-Torque Alignment Tube from Lot KTGG due to a manufacturing nonconformance. This could result in a delay of surgery or result in surgical intervention later on.
Identifiers
| code_info | Catalog Number/REF 7601-90001 LOT KTGG GTIN 10888857343948 |
|---|
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-0520-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.