Recall Z-0931-2021
K2M, Inc · initiated December 14, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON Spinal System
Codes / lots: Product Name / Catalog Number: 7601-04026 Serial/Lot Number(s) Affected: Lot KRBX Product Code (UDI): 10888857349582
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).
FDA-determined cause: Employee error
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.
Details
- Recall number
- Z-0931-2021
- Initiated
- December 14, 2020
- Posted by FDA
- January 27, 2021
- Terminated
- July 11, 2023
- Product code
- NKG – Posterior Cervical Screw System
- Quantity
- 248 units/1 each
- Distribution
- Domestic: Nationwide Foreign: Australia, Canada, Netherlands, Singapore
- Recalling firm
- K2M, Inc, Leesburg, VA