The Recall Desk
ModerateFDA (Devices)·Z-1778-2014·Announced 2014-06-18

Stryker Precision Neuro Drill Recall Due to Missing Notches

Stryker is recalling 6,481 Precision Neuro Drills because some cutting accessories may have missing or partial notches, which could affect their use with Elite Attachments.

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 defect involves missing notches on accessories without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Stryker Instruments Div. of Stryker Corporation is recalling 6,481 units of the 3.0mm x 3.8mm Precision Neuro Drill (Sterile). 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.

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. This defect could impact the proper fit or function of the accessories when used with the drill.

The affected products were distributed worldwide, including nationwide distribution in the United States. The specific part number is 5820-107-530, and the affected lot numbers include 13332017, 13332027, 13332037, 13333017, 13333027, 13334017, 13334027, 13336017, 13336027, 13346017, 13347017, 13347027, 13347037, and 14017017. Healthcare providers should stop using the affected devices and contact Stryker for further instructions.

The recalled product

Product
Stryker 3.0mm x 3.8mm Precision Neuro Drill 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 app
Manufacturer
Stryker Instruments Div. of Stryker Corporation
Category
Medical Device — Surgical Instruments
Hazard
Affected units
6,481

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 (15)

  • Part Number 5820-107-530
  • Lot Number 13332017
  • 13332027
  • 13332037
  • 13333017
  • 13333027
  • 13334017
  • 13334027
  • 13336017
  • 13336027
  • 13346017
  • 13347017
  • 13347027
  • 13347037
  • 14017017

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 →

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