Recall Z-1410-2021

Reason for recall

Interference condition between the 10mm Drill Guide Inserter and the inner shaft that mates with the inserters. As a result, inner shafts do not mate flush with the collet inserters, and splaying of the collet. If implant falls into the spinal cord may cause a spinal cord injury or Incomplete seating of the inserter to the implant could result in misalignment of the screws with the inserter screw guide, potentially causing malposition of the screws into the adjacent vertebral bodies

FDA-determined cause: Under Investigation by firm

Action taken

Stryker Spine issued Urgent Medical Device Recal letter that issued on 3/16. Letter states reason for recall, health risk and action to take: Our records indicate Stryker previously distributed catalog no. 3608-90033, Lot MNAJ 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 address referenced on the form. If you have any questions or concerns, please contact Stryker Spine Regulatory Compliance at 201-749-8090. On behalf of Stryker we thank you sincerely for your help and support in completing this action by the target date March 19, 2021.