Reported Dec 24, 2014 · Terminated

Specialty Audible Torque Wrench Mfg by: Stryker Spine, Catalog number IS3002XLP, Non-sterile. Used to final tighten to…

Stryker Spine

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Stryker Spine · 2 Pearl Ct · Allendale, NJ · 07401-1611

Is this the product you have?

  • Specialty Audible Torque Wrench Mfg byStryker 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
Lot codes and dates
  • Lot number 4279
Amount recalled
15 units

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 8, 2017 · Data as of Sep 19, 5:59 PM UTC

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