Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0874-2017·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.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a voluntary precautionary recall for a defect (corrosion) without reporting specific injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

Stryker Instruments Division of Stryker Corporation is voluntarily recalling specific lots of sterile MIS (Minimally Invasive Surgery) Toolsteel Burs. The product, identified by Product Number 8450-009-040 and Lot Number 16029017, is a single-use, sterile cutting accessory used to remove osseous material during surgical cases. A total of 1,257 units are affected by this recall.

The recall was initiated because the burs may exhibit signs of corrosion. The affected products were distributed worldwide, including nationwide in the United States and in Canada, Japan, the Netherlands, France, and the United Kingdom.

Healthcare facilities and consumers should stop using the affected burs and contact Stryker Instruments for further instructions or a replacement.

The recalled product

Product: 8450-009-040 4.0MM Precision Round, 13CM, 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…
Manufacturer: Stryker Instruments Div. of Stryker Corporation
Category: Medical Device — Surgical Instruments
Hazard: corrosion
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:16029017
Product Number: 8450-009-040

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 →

Same manufacturer · Stryker Instruments Div. of Stryker Corporation

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Same hazard · corrosion