Agency classClass IIOur severity:High FDA (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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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…
Manufacturer: Stryker Spine
Category: Medical Device — Surgical Instrument
Hazard: structural-failure
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 →

Same manufacturer · Stryker Spine

See all →

High
Stryker Monterey AL Implant Inserter Gold Button Detachment Risk
FDA (Devices) · 2025-04-09
High
Stryker Spine Monterey AL Implant Inserter Gold Unlock Button Separation Recall
FDA (Devices) · 2025-04-09
High
Stryker Spine Monterey AL Implant Inserter Recall Due to Potential Gold Button Separation
FDA (Devices) · 2025-04-09
High
Stryker Spine Monterey AL Implant Inserter Recalled for Potential Unlock Button Separation
FDA (Devices) · 2025-04-09
Moderate
AVS Anchor-C Cervical Cage Instructions for Use Labeling Correction
FDA (Devices) · 2024-10-02

Same hazard · structural failure