Stryker 1) XIA Torque Wrench 2) XIA 3 Torque Wrench 3) XIA Elegance… — Class II medical device recall Z-0375-2014
Terminated recall by Stryker Spine, reported 2013-11-27, distributed nationwide. Multiple complaints have reported that the hex tip of the torque wrench fracturing during final tightening.
| Recall number | Z-0375-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Spine, Allendale, NJ, United States |
| Recall initiated | 2013-09-24 |
| Classified | 2013-11-21 |
| Reported by FDA | 2013-11-27 |
| Terminated | 2016-10-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, CA, CL, DE, EG, ES, FR, HK, IE, IQ, IT, JP, KR, NL, NZ, TR |
| Lot numbers | 092793, 097089, 098401, 098525, 118823, 11A957, 11E035, 11E036, 11E038, 11E039, 11E040, 11E041, 11E042, 11E043, 11E044, 11E045, 11E046, 11E047, 11E048, 121098, 123746, 125708, 125709, 127051, 127179, 127510, 127647, 12A641, 12A646, 12D012, R11E036, R127647, R12A646 |
| Model numbers | 03807028, 48237028, 482397028 |
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.
Reason for recall
Multiple complaints have reported that the hex tip of the torque wrench fracturing during final tightening.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.