FDA Device recall Z-0931-2021
Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON Spinal System
- FDA Device
- Class II
- terminated
- Published 2021-02-03
On 2021-02-03 the FDA classified a Class II recall of Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON Spinal System by K2m, citing the Yukon polyaxial screw used in the Yukon Spinal System was incorrectly laser marked with size 5.0 mm (diameter) & 24 mm (length).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0931-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-12-14 |
| Published | 2021-02-03 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | K2m |
| Distribution | US |
Product
Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON Spinal System
Reason
The Yukon polyaxial screw used in the Yukon Spinal System was incorrectly laser marked with size 5.0 mm (diameter) & 24 mm (length).
Identifiers
| code_info | Product Name / Catalog Number: 7601-04026 Serial/Lot Number(s) Affected: Lot KRBX Product Code (UDI): 10888857349582 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0931-2021%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.