Recall Z-0931-2021 ยท NKG Posterior Cervical Screw System
K2M, Inc
Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON Spinal System
| Date | Jan 27, 2021 (initiated Dec 14, 2020) |
| Status | Terminated |
| Reason | The Yukon polyaxial screw used in the Yukon Spinal System was incorrectly laser marked with size 5.0 mm (diameter) & 24 mm (length). |
| Root cause | Employee error |
| Action | On 12/14/2020, Stryker Spine US Field Operations were notified of the action by teleconference and e-mail and instructed to identify and return all Lot KRBX screws to Stryker Spine. Affected Stryker Branches/Agencies, and hospitals that had previously been consigned product, will be issued a formal recall notification letter and product return documentation. |
| Quantity | 248 units/1 each |
| Distribution | Domestic: Nationwide Foreign: Australia, Canada, Netherlands, Singapore |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171444 | YUKON OCT Spinal System K2m, Inc., Aug 8, 2017 |