CLASS II Device recall · Reported 27 Nov 2013 · FDA Enforcement Report
Stryker XIA Torque Wrench XIA 3 Torque Wrench XIA Elegance recalled
Stryker Spine is recalling Stryker XIA Torque Wrench XIA 3 Torque Wrench XIA Elegance Short Torque Wrench, distributed nationwide in the US. The recall was initiated on 24 Sep 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0375-2014
- FDA event ID
- 66657
- Recalling firm
- Stryker Spine, Allendale, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Sep 2013
- FDA classified
- 21 Nov 2013
- Reported
- 27 Nov 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Spinal Implants
Timeline
| 24 Sep 2013 | Recall initiated by company | |
| 21 Nov 2013 | Classified by FDA | +58 days |
| 27 Nov 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Multiple complaints have reported that the hex tip of the torque wrench fracturing during final tightening.
Product as listed by the FDA
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.
Where it was distributed
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.
Questions about this recall
Is Stryker XIA Torque Wrench XIA 3 Torque Wrench XIA Elegance Short Torque Wrench recalled?
Yes. Stryker Spine recalled Stryker XIA Torque Wrench XIA 3 Torque Wrench XIA Elegance Short Torque Wrench on 24 Sep 2013. The recall is Class II and its status is Terminated. Recall number Z-0375-2014.
Why was it recalled?
Multiple complaints have reported that the hex tip of the torque wrench fracturing during final tightening.
Which lots are affected?
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
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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