Zimmer Silhouette Axial Torque Handle, Zimmer Spine, Inc., Minneapolis, MN; REF 7010-0151-01. Reusable instrument that is used to apply the appropriate torque to the lock nut that is part of the Silhouette Spinal Fixation System.

The firm's sales force was notified by an Urgent: Device Recall letter dated 10/7/08, which instructed them to stop using the instrument and quarantine it immediately; physically count all affected product in their territory and record data on the Inventory Return Certification Form; fax a copy of the completed form to Zimmer Spine; and return the affected devices with the completed Inventory Return Certification Form. User accounts/implanting physicians were informed by an Urgent: Device Recall letter dated 12/10/08 and instructed to monitor their patients.