Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON Spinal System
FDA device recall Z-0931-2021 · posted 2021-01-27 · Terminated
Recall details
- Recalling firm
- K2M, Inc
- Reason for recall
- The Yukon polyaxial screw used in the Yukon Spinal System was incorrectly laser marked with size 5.0 mm (diameter) & 24 mm (length).
- Action taken
- 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.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- NKG
- Quantity affected
- 248 units/1 each
- Distribution
- Domestic: Nationwide Foreign: Australia, Canada, Netherlands, Singapore
- Date initiated
- 2020-12-14
- Date posted
- 2021-01-27
- Date terminated
- 2023-07-11
- Location
- Leesburg, VA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| YUKON OCT Spinal System (K171444) | K2m, Inc. | 2017-08-08 |