Wrench

Axial Torque Limiting Driver (1st generation)

A component failure could cause a situation where the applied torque was significantly higher than the calibrated torque setting.

Firebird Spinal Fixation System Torque Limiting Handle (PN 52-1512)

There is a possibility that the device may deliver a torque value less than the required setting after initial sterilization. In worst case, the unexpected drop in torque value may lead to the spinal construct loosening and requiring corrective surgical intervention.

S4C Occiput Torque Wrench F/Set Screw; used to tighten the S4 Cervical Spinal System clamping screws with a defined torque 2.8 Nm for tightening the clamping sc

A FW103R torque wrench that was improperly reassembled after reprocessing caused a screw to break during implantation due to too much torque. The firm did not include instructions for reassembly after reprocessing.

Lineum HF Torque Handle Limit (Lineum) Model Number 14-525035

Biomet is recalling the Lineum HF Torque Handle Limit (Lineum) and Torque Limiting Handle (Aspen/ Alpine) due to the supplier withdrawing it from the market for component updates or reconfiguration.

Torque Limiting Handle (Aspen/ Alpine) Model Number 6200-1109

Biomet is recalling the Lineum HF Torque Handle Limit (Lineum) and Torque Limiting Handle (Aspen/ Alpine) due to the supplier withdrawing it from the market for component updates or reconfiguration.

DePuy Spine EXPEDIUM Offset Torque Wrench

A component within the handle of the Expedium Offset Torque Wrench is prematurely wearing, potentially resulting in the instrument recording torque values outside of the specification.

Zimmer Silhouette Axial Torque Handle, Zimmer Spine, Inc., Minneapolis, MN; REF 7010-0151-01.

Some of the torque wrenches apply less than the minimum torque to the screw locking cap when the torque indicators are aligned as described in the surgical technique.

Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618A

Due to manufacturing processing error, wrench causing stripping when torqueing nuts.