Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON Spinal System
FDA Recall Z-0931-2021 · Posted 2021-01-27
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Recalling FirmK2M, Inc
Recall StatusTerminated
Product CodeNKG
Date Initiated2020-12-14
Date Terminated2023-07-11
Product Quantity248 units/1 each
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).
Firm 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.
Root Cause
Employee error
Distribution Pattern
Domestic: Nationwide Foreign: Australia, Canada, Netherlands, Singapore
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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