Reported Jun 18, 2014 · Terminated

Stryker 3.0mm x 3.8mm Neuro Drill Less Aggressive Sterile Product Usage: The devices are intended to be used to cut…

Stryker Instruments Div. of Stryker Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Stryker Instruments Div. of Stryker Corporation · 4100 E Milham Ave · Portage, MI · 49002-9704

Is this the product you have?

  • Stryker 3.0mm x 3.8mm Neuro Drill
  • Less Aggressive Sterile Product UsageThe 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 maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis
Lot codes and dates
    • Part Number 5820-107-430S1
    • Lot Number 14003017
    • 14005017
Amount recalled
916

This recall covers 32 products

The agency filed one notice per product. You are reading one of them; the other 31 are below.

19 more are in the archive.

Where it was sold

  • Nationwide

Why it was recalled

There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 6, 2015 · Data as of Sep 19, 5:27 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.