The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-2238-2016·Announced 2016-07-27

Stryker 2.3mm Tapered Routers Recalled Due to Breakage Risk

Stryker is recalling 2.3mm Tapered Routers because a variation in flute depth may cause breakage, posing a risk of injury to critical soft tissue.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and the source text explicitly states that injury to critical soft tissue requiring surgical intervention may occur, which aligns with the rubric criteria for Severe severity involving significant injury reports or potential.

Plain-English summary

Stryker Instruments Div. of Stryker Corporation is recalling 3,163 units of the 2.3MM Tapered Router, Product Number 5407-FA2-023. These cutting accessories are used in medical applications including Neuro, Spine, ENT, Craniofacial, and Sternotomy procedures, and are intended for use with the Stryker CORE system.

The recall was initiated because a variation in flute depth was observed on the routers. This variation may make the devices more susceptible to breakages during use. The FDA classifies this as a Class II recall.

The risk to health is that injury to critical soft tissue requiring surgical intervention may occur if the router breaks. The affected units were distributed worldwide, including the United States, Netherlands, Canada, Japan, Switzerland, and the United Kingdom. Specific lot numbers are listed in the official recall record.

The recalled product

Product
2.3MM Tapered Router, Product Number 5407-FA2-023 A router is a cutting accessory used in the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/Otology /Neurotology/ Otorhinolaryngology; Craniofacial (bones of the skull and supraorbital region); and…
Manufacturer
Stryker Instruments Div. of Stryker Corporation
Category
Medical Device — Surgical Instruments
Hazard
Affected units
3,163

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 (14)

  • Lot numbers: 15077027
  • 15077067
  • 15077097
  • 15078087
  • 15105017
  • 15108017
  • 15108047
  • 15108077
  • 15108087
  • 15108097
  • 15146017
  • 15146027
  • 15146037
  • 15146047

Distribution

Distributed nationwide across the United States.

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