Zimmer Silhouette Axial Torque Handle, Zimmer Spine, Inc., Minneapolis, MN; REF 7010-0151-01. Reusable instrument that i

FDA device recall Z-1031-2009 · posted 2009-03-04 · Terminated

Recall details

Recalling firm

Zimmer Inc.

Reason for recall

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.

Action taken

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.

Root cause

Process control

Status

Terminated

Product code

HXC

Quantity affected

76

Distribution

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

Date initiated

2008-11-07

Date posted

2009-03-04

Date terminated

2009-12-22

Location

Warsaw, IN