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FDAFDA · Food and drugs·Recall number Z-0803-2015

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.

Published December 24, 2014 · Recall initiated: October 6, 2014

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Stryker has received a complaint from customers relating to a fracture during the use of the Specialty Audible Torque Wrench in surgery.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Stryker Spine
Distributor
Distributed to GA, IN, MI, NJ, OH, PA, TX & VA.
Lot
Lot number 4279
Risk classification
Class II
Area (FDA)
device
Country
United States

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