The Recall Desk
HighFDA (Devices)·Z-0870-2017·Announced 2016-12-28

Stryker Recalls Sterile Minimally Invasive Surgery Burs Due to Corrosion

Stryker is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because they may exhibit signs of corrosion.

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 potential defect (corrosion) that poses a risk of harm during surgery, but the source text does not report any specific injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Stryker Instruments Division of Stryker Corporation is voluntarily recalling specific lots of sterile MIS Toolsteel Burs. The recall is being conducted because the burs may exhibit signs of corrosion.

The affected product is the 8470-009-030 3.0MM Precision Round, 16CM, single use, Sterile bur. These tools are part of the Stryker MIS (Minimally Invasive Surgery) product offering and are used to remove osseous material during surgical cases. Each cutting accessory consists of a shank with a notch that fits in the attachment and a head connected to the shank that removes material using machined flutes.

A total of 1,257 units are included in this recall. The affected lots are 16049017 and 16053017. The products were distributed worldwide, including nationwide in the United States and in Canada, Japan, the Netherlands, France, and the United Kingdom. Healthcare facilities and users should stop using the affected burs and contact Stryker for further instructions.

The recalled product

Product
8470-009-030 3.0MM Precision Round, 16CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseous material during surgical cases. Each cutting accessory consists of: " A shank (B) with a notch (A), that fits in the attachmen
Manufacturer
Stryker Instruments Div. of Stryker Corporation
Category
Medical Device — Surgical Instruments
Hazard
Affected units
1,257

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)

  • Lot Number(s):16049017 & 16053017
  • Product Number: 8470-009-030

Distribution

Distributed nationwide across the United States.

The notice also names 34 states specifically:

Part of a larger recall action

This product is one of 7 recalled by Stryker Instruments Div. of Stryker Corporation 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 7 products in this recall →

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