FDA-Device2014-12-24Class II
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.
Stryker Spine
Hazard
Stryker has received a complaint from customers relating to a fracture during the use of the Specialty Audible Torque Wrench in surgery.
Sold states
Distributed to GA, IN, MI, NJ, OH, PA, TX & VA.
Affected count
15 units
Manufactured in
2 Pearl Ct, N/A, Allendale, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0803-2015Don't want to check this manually?
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