The Recall Desk
ModerateFDA (Devices)·Z-0868-2017·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 a voluntary precautionary action for a potential defect (corrosion) without reported 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 Toolsteel Burs. The recall is being conducted because the burs may exhibit signs of corrosion.

The affected product is the 8450-107-530 3.0MM Precision Match Head, 13CM, single use, Sterile. These burs are part of the Stryker MIS (Minimally Invasive Surgery) product offering and are used to remove osseous material during surgical cases. The specific lot number is 16032017 and the product number is 8450-009-030.

A total of 1,257 units are involved in this recall. The products were distributed worldwide, including nationwide in the United States and in Canada, Japan, the Netherlands, France, and the United Kingdom. The source text does not specify instructions for consumers or healthcare providers regarding the disposal or return of these devices.

The recalled product

Product
8450-107-530 3.0MM Precision Match Head, 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 atta
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:16032017
  • Product Number: 8450-009-030

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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