Z-0803-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 24, 2014
- Initiation Date
- October 6, 2014
- Termination Date
- May 8, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15 units
Product Description
Specialty Audible Torque Wrench Mfg by: Stryker Spine, Catalog number IS3002XLP, Non-sterile. Used to final tighten to 12 Nm the blocker of the XIA 3, Hooks, Monoaxial Screws, Rod to Rod Connectors and Off-set connectors.
Reason for Recall
Stryker has received a complaint from customers relating to a fracture during the use of the Specialty Audible Torque Wrench in surgery.
Distribution Pattern
Distributed to GA, IN, MI, NJ, OH, PA, TX & VA.
Code Information
Lot number 4279