The Recall Desk
ModerateFDA (Devices)·Z-1767-2014·Announced 2014-06-18

Stryker 6.0mm Egg Bur Recall Due to Missing Notches

Stryker is recalling 65 units of 6.0mm Egg Bur sterile surgical instruments because some units have missing or partial notches.

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 does not report any injuries or illnesses, fitting the criteria for a moderate severity recall involving a potential functional defect.

Plain-English summary

Stryker Instruments Div. of Stryker Corporation is recalling 65 units of the Stryker 6.0mm Egg Bur sterile surgical instrument. The recall involves Part Number 5820-15-60, Lot Number 14002017. These devices are intended to be used to cut bone and bone-related tissue during neurosurgery, including craniotomy and spinal surgery, as well as ear, nose and throat (ENT), orthopedic, and general surgical applications.

The recall was initiated because there may be missing notches, partial notches, or no notches at all in some Cutting Accessories that are used with the Elite Attachments. The source text does not report any specific injuries or illnesses associated with this defect.

The affected products were distributed worldwide, including nationwide distribution in the United States. Healthcare facilities and users should check their inventory for the specific part and lot numbers listed and stop using the affected devices.

The recalled product

Product
Stryker 6.0mm Egg Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including ma
Affected units
65

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)

  • Part Number 5820-15-60
  • Lot Number 14002017

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 32 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 32 products in this recall →

Same manufacturer · Stryker Instruments Div. of Stryker Corporation

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