Device product
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.
Z-0803-2015
Product summary
- Firm
- Stryker Spine
- Event
- Event 69784
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15 units
- Official record key
device-enforcement:Z-0803-2015
Official wording
Reason: Stryker has received a complaint from customers relating to a fracture during the use of the Specialty Audible Torque Wrench in surgery.
Code information: Lot number 4279
Distribution pattern: Distributed to GA, IN, MI, NJ, OH, PA, TX & VA.
Derived failure modes
-
Unknown
Stryker has received a complaint from customers relating to a fracture during the use of the Specialty Audible Torque Wrench in surgery.