The Recall Desk
ModerateFDA (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.

What this means for you

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 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: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 →

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