Reported Mar 27, 2013 · Terminated

PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog Number: l5613K. Implants in support for fixed…

Keystone Dental 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: Keystone Dental Inc · 144 Middlesex Tpke · Burlington, MA · 01803-4403

Is this the product you have?

  • PrimaConnex Tapered Implant TC, SD Internal Connection 3.5
  • x 10mm Catalog Numberl5613K. Implants in support for fixed bridgework
Lot codes and dates
  • Lot Number12857
Amount recalled
120 units

Where it was sold

Why it was recalled

Mislabeled: Cover screw that was in the package was a WD cover screw and not a SD cover screw as labeled

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 Sep 26, 2013 · 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.