Reported Jun 12, 2013 · Terminated

Straight Impactor - Dorado IBC, Part Number: SI02140. The device is used to position implants after they have been…

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?

  • Straight Impactor - Dorado IBC
  • Part NumberSI02140. The device is used to position implants after they have been inserted into the disc space during implantation of intervertebral body fusion devices
Lot codes and dates
  • Lot number20856
Amount recalled
10

Where it was sold

Why it was recalled

During two separate occasions an impactor plate on the handle broke off while being struck by a mallet.

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 Oct 8, 2014 · Data as of Sep 19, 6:17 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.