Recall Z-0382-2013— Stryker Spine
Class II · Terminated
Class II FDA medical device recall by Stryker Spine, initiated 2012-08-09, terminated 2015-09-30. FDA's recall record names no specific 510(k) clearance for this event. Product: SPECIALTY AUDIBLE TORQUE WRENCH, XIA IS2217XLP MFG BY: STRYKER SPINE 2 PEARL COURT ALLENDALE NJ 07401-1677 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: Multiple complaints have reported the hex tip of the torque wrench fracturing during final tightening..
- Recalling firm
- Stryker Spine
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-08-09
- Terminated
- 2015-09-30
- Firm location
- Allendale, NJ, United States
Product description
SPECIALTY AUDIBLE TORQUE WRENCH, XIA IS2217XLP MFG BY: STRYKER SPINE 2 PEARL COURT ALLENDALE NJ 07401-1677 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.