CLASS II Device recall · Reported 28 Nov 2012 · FDA Enforcement Report

Stryker Mantis Torque Wrench recalled by Stryker Spine

Stryker Spine is recalling Stryker Mantis Torque Wrench, distributed nationwide in the US. The recall was initiated on 9 Aug 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesClass I device, 510(K) exempt Catalog Number: 48287028 Lot Number: 098400

Quantity recalled19 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-0381-2013
FDA event ID: 63386
Recalling firm: Stryker Spine, Allendale, NJ
Classification: Class II
Status: Terminated
Recall initiated: 9 Aug 2012
FDA classified: 19 Nov 2012
Reported: 28 Nov 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Spinal Implants

Timeline

9 Aug 2012	Recall initiated by company
19 Nov 2012	Classified by FDA	+102 days
28 Nov 2012	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

Multiple complaints have reported the hex tip of the torque wrench fracturing during final tightening.

Product as listed by the FDA

Stryker MANTIS TORQUE WRENCH REF 48287028 Manufactured by: Stryker pine SAS Z.I MARTICOT-33610-CESTAS-FRANCE +33 (0)5.57.97.06.30 http://www.stryker.com Distributed in the USA by: Stryker Spine, 2 Pearl Ct. Allendale NJ 07401-1677 USA +1-201-780-8000 The Xia 3/Mantis Redux/Specialty Audible Torque Wrenches are used to final tighten the blocker of the Xia 3/ Mantis Redux Polyaxial Screws, Hooks, Monoaxial Screws, Rod to Rod Connectors and Off-set connectors. The Torque Wrench is a t-handle deflection beam torque wrench with a 5 mm hex tip. The instrument allows the controlled application of 12 Nm torque via a visual indicator on the bell shaped cylinder just below the handle. The Specialty Audible Torque Wrench has an extra feature where it creates and audible "click" when the desired final tightening torque is reached.

Where it was distributed

Worldwide Distribution - USA (nationwide) and internationally to Australia, Canada, France, Germany, Netherlands, Japan, Spain, Denmark, Switzerland, and the United Kingdom.

Nationwide

Questions about this recall

Why was it recalled?

Multiple complaints have reported the hex tip of the torque wrench fracturing during final tightening.

Which lots are affected?

Class I device, 510(K) exempt Catalog Number: 48287028 Lot Number: 098400

Where was it sold?

Worldwide Distribution - USA (nationwide) and internationally to Australia, Canada, France, Germany, Netherlands, Japan, Spain, Denmark, Switzerland, and the United Kingdom.

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.

Other products in this recall event

2 other products · FDA event 63386

This product is part of a recall event; the main page for the event is Specialty Audible Torque Wrench, Xia Is2217xlp recalled by Stryker Spine.

Reported	Class	Recall	Company	Reason	Where
28 Nov 2012	CLASS II	Specialty Audible Torque Wrench, Xia Is2217xlp recalled by Stryker Spine	Stryker Spine	Other	Nationwide
28 Nov 2012	CLASS II	Stryker Xia 3 Torque Wrench recalled by Stryker Spine	Stryker Spine	Other	Nationwide

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