DePuy Spine EXPEDIUM Offset Torque Wrench Product Code 2797-29-510 The device is intended for use during the final tight

FDA device recall Z-0685-2013 · posted 2013-01-16 · Terminated

Recall details

Recalling firm

DePuy Spine, Inc.

Reason for recall

A component within the handle of the Expedium Offset Torque Wrench is prematurely wearing, potentially resulting in the instrument recording torque values outside of the specification.

Action taken

DePuy Spine issued an Urgent - Voluntary Product Recall Notification dated July 24, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to disconstinue the use of the affected product and to remove the EXPEDIUM Offset Torque Wrenches from service and return to DePuy Synthes Spine until direction can be provided by DePuy Synthes Spine regarding a replacement torque limiting device. For questions regarding this recall call 508-828-3769.

Root cause

Device Design

Status

Terminated

Product code

HXC

Quantity affected

140 units

Distribution

Worldwide Distribution - USA (nationwide) and internationally to Belgium, Egypt, Ireland, Italy, Portugal, and the UK.

Date initiated

2012-07-24

Date posted

2013-01-16

Date terminated

2013-12-30

Location

Raynham, MA