Recall Z-0803-2015— Stryker Spine
Class II · Terminated
Class II FDA medical device recall by Stryker Spine, initiated 2014-10-06, terminated 2017-05-08. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Stryker has received a complaint from customers relating to a fracture during the use of the Specialty Audible Torque Wrench in surgery..
- Recalling firm
- Stryker Spine
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-10-06
- Terminated
- 2017-05-08
- Firm location
- Allendale, NJ, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.