Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Yukon OCT Spinal System Yukon Anti-Torque Alignment Tube - Product Usage: The Anti-Torque Alignment Tube (the Alignment Tube ) provides counter rotation to reduce the torque applied to the anatomy when the size 15 Torque limiting shaft (the shaft is used to tighten the Yukon Set Screw to the specified torque.

FDA Recall Z-0520-2021 · Posted None

Recalling FirmK2M, Inc
Recall StatusTerminated
Product CodeNKG
Date Initiated2020-11-03
Date Terminated2021-01-12
Product Quantity4 devices

Reason for Recall

Shafts do not pass through the inner cannula of the Anti-Torque Alignment Tube from Lot KTGG due to a manufacturing nonconformance. This could result in a delay of surgery or result in surgical intervention later on.

Firm Action

Our records indicate Stryker previously distributed catalog no. 7601-9001, Lot KTGG to your location in a Stryker Loaner Set. The nonconforming instrument was subsequently identified and quarantined during routine processing of loaner sets by Stryker at its Leesburg facility. This communication is being made for notification purposes only. The only action requested of you is to complete the Business Reply form found on the following page and return it to the email addresses referenced in the form. If you have any questions or concerns, please contact Stryker Regulatory Compliance at 201-749-8090. On behalf of Stryker we thank you sincerely for your help and support in completing the Business Reply Form and returning it to Stryker by November 6th, 2020.

Root Cause

Nonconforming Material/Component

Distribution Pattern

US Nationwide distribution.

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.

↑