Stryker MANTIS TORQUE WRENCH REF 48287028 Manufactured by: Stryker… — Class II medical device recall Z-0381-2013
Terminated recall by Stryker Spine, reported 2012-11-28, distributed nationwide. Multiple complaints have reported the hex tip of the torque wrench fracturing during final tightening.
| Recall number | Z-0381-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Spine, Allendale, NJ, United States |
| Recall initiated | 2012-08-09 |
| Classified | 2012-11-19 |
| Reported by FDA | 2012-11-28 |
| Terminated | 2015-09-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CH, DE, DK, ES, FR, GB, JP, NL |
| Quantity | 19 units |
| Lot numbers | 098400 |
| Model numbers | 48287028 |
Product
Stryker MANTIS TORQUE WRENCH REF 48287028 Manufactured by: Stryker pine 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 Ct. Allendale NJ 07401-1677 USA +1-201-780-8000 The Xia 3/Mantis Redux/Specialty Audible Torque Wrenches are used to final tighten the blocker of the Xia 3/ Mantis Redux Polyaxial Screws, Hooks, Monoaxial Screws, Rod to Rod Connectors and Off-set connectors. The Torque Wrench is a t-handle deflection beam torque wrench with a 5 mm hex tip. The instrument allows the controlled application of 12 Nm torque via a visual indicator on the bell shaped cylinder just below the handle. The Specialty Audible Torque Wrench has an extra feature where it creates and audible "click" when the desired final tightening torque is reached.
Reason for recall
Multiple complaints have reported 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.