Z-0375-2014Class II

Stryker 1) XIA Torque Wrench 2) XIA 3 Torque Wrench 3) XIA Elegance Short Torque Wrench Manufactured by...

Name: Z-0375-2014 Stryker 1) XIA Torque Wrench 2) XIA 3 Torque Wrench 3) XIA Elegance Short Torque Wrench Manufactured by...
Creator: Stryker Spine
Published: 2013-09-24
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2013-09-24 / Terminated / root cause: manufacturing process

FDA source

Stryker Spine began a recall of Stryker 1) XIA Torque Wrench 2) XIA 3 Torque Wrench 3) XIA Elegance Short Torque Wrench Manufactured by: Stryker Spine SAS Z.I. Marticot -33610 -CESTAS -FRANCE... on 2013-09-24. FDA classified it as Class II and gives the reason as "Multiple complaints have reported that the hex tip of the torque wrench fracturing during final tightening". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0375-2014
Classification: Class II
Status: Terminated
Initiated: 2013-09-24
Posted: 2013-11-21
Terminated: 2016-10-13
Recalling firm: Howmedica Osteonics Corp
Product: Stryker 1) XIA Torque Wrench 2) XIA 3 Torque Wrench 3) XIA Elegance Short Torque Wrench Manufactured by: Stryker Spine SAS Z.I. Marticot -33610 -CESTAS -FRANCE +33 (0) 5.57.97.06.30 http://www.stryker.com Distributed in the USA by: Stryker Spine 2 Pearl Court Allendale, NJ 07401-1677 USA +1-201-760-8000 XIA 3 Spinal System- Intended for use in the noncervical spine. When used as an anterior/anterolateral and posterior, non cervical pedicle and on-pedicled fixation system, the XIA 3 Spinal system is intended to provide additional support during fusion autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities; degenerate disc disease (DDD) ; spondylolisthesis; trauma spinal stenosis; curvatures; tumor; pseudoarthrosis and failed previous fusion. XIA - Intended for anterior/anterolateral and posterior, non cervical pedicle and non-pedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease; spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis and failed previous fusion.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Multiple complaints have reported that the hex tip of the torque wrench fracturing during final tightening.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Stryker sent an Urgent Medical Device Removal Notification letter dated September 25, 2013, with product accountability forms to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and hospital locations to identify any affected product, reconcile any Torque Wrenches with Catalog Number with Lot Numbers referenced in the letter. Customers were asked to fax a copy of the Customer Response Form to Regulatory Compliance at 855-632-9049 or you email it to [email protected]. Customers were asked to return the affected product using the enclosed mailing label to: RECALL RA 2013-105 Stryker Spine 59 Route 17 South, Allendale, New Jersey 07401 branches/agencies, the field and surgeons via Fed Ex on starting on 9/24/2013. For questions regarding this recall call 201-760-8298. Stryker sent another Urgent Medical Device Removal Notification Letter dated 1/29/2014 which included additional lots and one product.
Quantity in commerce: 220 US units; 431 OUS units
Distribution: Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Canada, Chile, France, Canada, Germany, Hong Kong, Ireland, Italy, Japan, Korea, Netherlands, New Zealand, Spain, Iraq, Egypt, and Turkey.
Product codes and lots: Medical Device Listing Number E207315 1) XIA Torque Wrench Catalog # 03807028 Lot # 127510, 092793, 097089, 11E038, 11E039, 11E040, 11E041, 123746, 127179, &12D012 2) XIA 3 Torque Wrench Catalog # 48237028 Lot # 11E042, 11E044, 11E047, 098525, 118823, 11E043, 11E045, 11E046, 11E048, 127647, R127647, 12A646, & R12A646 3) XIA Elegance Short Torque Wrench Catalog # 482397028 Lot # 11A957, 11E035, 11E036, R11E036, & 121098 4) Mantis Redux Torque Wrench Reference Number 48287028 Lot # 098401, 125708, 125709, 127051 & 12A641

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0375-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0375-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-21

Product code LXH

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)