The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0381-2013·Announced 2012-11-28

Stryker Mantis Torque Wrench Recalled for Hex Tip Fracture

Stryker Spine is recalling 19 Mantis Torque Wrenches because the hex tip may fracture during use. The recall covers units distributed in the US and internationally.

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 use, but the source text does not report any 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 19 units of the Mantis Torque Wrench (Catalog Number 48287028, Lot Number 098400). The device is a Class I medical instrument used to tighten specific spinal fixation components. The recall was initiated after multiple complaints reported that the hex tip of the torque wrench fractured during the final tightening process.

The affected units were distributed nationwide in the United States and internationally to Australia, Canada, France, Germany, the Netherlands, Japan, Spain, Denmark, Switzerland, and the United Kingdom. The source text does not report any specific injuries or illnesses associated with these fractures.

Healthcare providers and facilities should stop using the affected torque wrenches and contact Stryker Spine for further instructions on the recall.

The recalled product

Product
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…
Manufacturer
Stryker Spine
Category
Medical Device — Surgical Instrument
Hazard
Affected units
19

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 (2)

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

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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