Recall Z-0520-2021 ยท NKG Posterior Cervical Screw System
K2M, Inc
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.
| Date | Nov 3, 2020 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| 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 |
| Quantity | 4 devices |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K193129 | Yukon OCT Spinal System K2m, Inc., Feb 7, 2020 |