Recall Z-0382-2013 ยท LXH Orthopedic Manual Surgical Instrument
Stryker Spine
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
| Date | Nov 19, 2012 (initiated Aug 9, 2012) |
| Status | Terminated |
| Reason | Multiple complaints have reported the hex tip of the torque wrench fracturing during final tightening. |
| Root cause | Nonconforming Material/Component |
| Action | Stryker Spine sent an Urgent Medical Device Removal Notification letter/Product Accountability Forms dated August 9, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. For questions regarding this recall call 201-760-8150. |
| Quantity | 28 units |
| Distribution | Worldwide Distribution - USA (nationwide) and internationally to Australia, Canada, France, Germany, Netherlands, Japan, Spain, Denmark, Switzerland, and the United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.