The Recall Desk
HighFDA (Devices)·Z-0382-2013·Announced 2012-11-28

Stryker Spine Recalls Specialty Audible Torque Wrenches Due to Fracturing Tips

Stryker Spine is recalling 28 units of Specialty Audible Torque Wrenches because the hex tips have fractured during use.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a structural defect (fracturing tip) that poses a risk of harm during surgical use, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Stryker Spine is recalling 28 units of the Specialty Audible Torque Wrench (Catalog Number IS2217XLP, Lot Numbers 2576 and 2756). The recall was initiated after multiple complaints reported that the hex tip of the torque wrench fractured during the final tightening process.

The affected instruments are Class I medical devices used to final tighten the blockers of specific spinal fixation systems, including the Xia 3 and Mantis Redux Polyaxial Screws, Hooks, Monoaxial Screws, Rod to Rod Connectors, and Off-set connectors. The devices were distributed worldwide, including in the United States, Australia, Canada, France, Germany, the Netherlands, Japan, Spain, Denmark, Switzerland, and the United Kingdom.

Healthcare providers and facilities should stop using the affected torque wrenches immediately. Users should contact Stryker Spine for instructions on how to return the devices for replacement or repair.

The recalled product

Product
SPECIALTY AUDIBLE TORQUE WRENCH, XIA IS2217XLP MFG BY: STRYKER SPINE 2 PEARL COURT ALLENDALE NJ 07401-1677 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 Scr
Manufacturer
Stryker Spine
Category
Medical Device — Surgical Instrument
Hazard
Affected units
28

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Class I device
  • 510(K) exempt Catalog Number: IS2217XLP Lot Number: 2576
  • 2756

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Stryker Spine under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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