Reported Aug 21, 2013 · Terminated

Invue Solid Driver, Tipped, AO. Part Number: 11-70083. Allows the user to retain the screw when changing axis of…

SpineFrontier, Inc.

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: SpineFrontier, Inc. · 500 Cummings Ctr Ste 3500 · Beverly, MA · 01915-6516

Is this the product you have?

  • Invue Solid Driver, Tipped, AO
  • Part Number11-70083. Allows the user to retain the screw when changing axis of insertion during fixation of spinal intervertebral
Lot codes and dates
  • Lot Number
    • 011836-0001
    • 011981-001
Amount recalled
9

This recall covers 2 products

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

Where it was sold

Why it was recalled

The nipple of the tipped driver broke off when surgeons were attempting to insert the screw.

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 Jan 10, 2014 · Data as of Sep 19, 6:16 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.