CLASS II Device recall · Reported 24 Dec 2014 · FDA Enforcement Report

Specialty Audible Torque Wrench recalled by Stryker Spine

Stryker Spine is recalling Specialty Audible Torque Wrench, distributed in 8 states. The recall was initiated on 6 Oct 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot number 4279

Quantity recalled15 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0803-2015
FDA event ID: 69784
Recalling firm: Stryker Spine, Allendale, NJ
Classification: Class II
Status: Terminated
Recall initiated: 6 Oct 2014
FDA classified: 15 Dec 2014
Reported: 24 Dec 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Spinal Implants

Timeline

6 Oct 2014	Recall initiated by company
15 Dec 2014	Classified by FDA	+70 days
24 Dec 2014	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

Distributed to GA, IN, MI, NJ, OH, PA, TX & VA.

Georgia Indiana Michigan New Jersey Ohio Pennsylvania Texas Virginia

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Lot number 4279

Where was it sold?

Distributed to GA, IN, MI, NJ, OH, PA, TX & VA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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