Reported May 15, 2013 · Terminated

Mercury Spinal System DIA 5.5 x 100mm Lordosed Rod, Part Number: 60100-100. Intended to provide immobilization and…

Spinal Elements, Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

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: Spinal Elements, Inc · 3115 Melrose Dr · Carlsbad, CA · 92010-6690

Is this the product you have?

  • Mercury Spinal System DIA 5.5 x 100mm Lordosed Rod
  • Part Number60100-100. Intended to provide immobilization and stabilization of the spine in skeletally mature patients
Lot codes and dates
  • Lot Number080589
Amount recalled
68 units total

This recall covers 21 products

The agency filed one notice per product. You are reading one of them; the other 20 are below.

8 more are in the archive.

Where it was sold

Why it was recalled

Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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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 7, 2013 · Data as of Sep 19, 4:51 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.