FDA Medical Device Recalls (openFDA)
K2M, Inc: Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON Spinal System
- Recall number
- Z-0931-2021
- Recalling firm
- K2M, Inc
- Product
- Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON Spinal System
- Status
- Terminated
- Initiated
- 2020-12-14
- Posted
- 2021-01-27
- Terminated
- 2023-07-11
- 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
- Lot, serial or model codes
- Product Name / Catalog Number: 7601-04026 Serial/Lot Number(s) Affected: Lot KRBX Product Code (UDI): 10888857349582
- 510(k) numbers
- ["K171444"]
- PMA numbers
- not on file
- Product code
- NKG
- Firm FEI
- 3008599177
- Firm city
- Leesburg
- Firm state
- VA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28