Stryker Spine: Medical Device Recall in 2012 - (Recall #: Z-0381-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: August 9, 2012

Date Posted: November 28, 2012

Recall Number: Z-0381-2013

Event ID: 63386

Reason for Recall:

Multiple complaints have reported the hex tip of the torque wrench fracturing during final tightening.

Status: Terminated

Product Quantity: 19 units

Code Information:

Class I device, 510(K) exempt Catalog Number: 48287028 Lot Number: 098400

Distribution Pattern:

Worldwide Distribution - USA (nationwide) and internationally to Australia, Canada, France, Germany, Netherlands, Japan, Spain, Denmark, Switzerland, and the United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated