Medical device recalls Moderate risk

Straumann USA, LLC recalls Drill set long, drill stop compatible for 4.8mm diameter implant, Article Number 040.447S Endosseous dental implant dri…

Recall date
October 27, 2014
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0981-2015
FDA classification
Class II
Brand / firm
Straumann USA, LLC
Sold / distributed
Nationwide in the following states: AZ, CA, CO,CT, FL, IA, IL, IN, LA, MA, MD, ME, MN, MO, NC, NJ, NY, OH, OK, OR, PA, RI, TX, VA and WV. Worldwide in the following countries by Institut Straumann AG distribution network: Austria, Australia, Canada, Germany, Spain, Finland, France, United Kingdom,…

Why it was recalled

Drill set may contain incorrect drill.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Drill set long, drill stop compatible for 4.8mm diameter implant, Article Number 040.447S Endosseous dental implant drill set.

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