Z-0685-2013Class II

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

Name: Z-0685-2013 DePuy Spine EXPEDIUM Offset Torque Wrench Product Code 2797-29-510 The device is intended for use during the...
Creator: DePuy Spine, Inc.
Published: 2012-07-24
License: https://open.fda.gov/license/

DePuy Spine, Inc. / initiated 2012-07-24 / Terminated / root cause: design

FDA source

DePuy Spine, Inc. began a recall of DePuy Spine EXPEDIUM Offset Torque Wrench Product Code 2797-29-510 The device is intended for use during the final tightening of an Expedium Offset Spinal... on 2012-07-24. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0685-2013
Classification: Class II
Status: Terminated
Initiated: 2012-07-24
Posted: 2013-01-16
Terminated: 2013-12-30
Recalling firm: DePuy Spine, Inc.
Product: DePuy Spine EXPEDIUM Offset Torque Wrench Product Code 2797-29-510 The device is intended for use during the final tightening of an Expedium Offset Spinal Construct.
Product code: HXC Wrench
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.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 140 units
Distribution: Worldwide Distribution - USA (nationwide) and internationally to Belgium, Egypt, Ireland, Italy, Portugal, and the UK.
Product codes and lots: All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0685-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0685-2013	Class II	Terminated	Voluntary: Firm initiated	2013-01-23	2013-01-16

Product code HXC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)