—#74904

Product

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.

FDA product code: HXC — Wrench
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Lots P050120 and P041466.

Why it was recalled

Some of the torque wrenches apply less than the minimum torque to the screw locking cap when the torque indicators are aligned as described in the surgical technique.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Zimmer Inc.
Address: 345 E Main St, Warsaw, Indiana 46580-2746

Distribution

Distribution pattern: Worldwide Distribution --- USA including states of California, Minnesota, Ohio, Pennsylvania, and Tennessee, and countries of Denmark, Germany, Iran, Italy, Russia, Singapore, Spain, Switzerland, and United Kingdom.

Timeline

Recall initiated: 2008-11-07
Posted by FDA: 2009-03-04
Terminated: 2009-12-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #74904. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.