PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: January 21, 2015 Initiated: October 27, 2014 #Z-0981-2015

Product Description

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

Reason for Recall

Drill set may contain incorrect drill.

Details

Recalling Firm
Straumann USA, LLC
Units Affected
362 pieces
Distribution
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, Netherlands, Belgium, Switzerland, Ireland, Italy.
Location
Andover, MA

Frequently Asked Questions

What product was recalled?
Drill set long, drill stop compatible for 4.8mm diameter implant, Article Number 040.447S Endosseous dental implant drill set.. Recalled by Straumann USA, LLC. Units affected: 362 pieces.
Why was this product recalled?
Drill set may contain incorrect drill.
Which agency issued this recall?
This recall was issued by the FDA Devices on January 21, 2015. Severity: Moderate. Recall number: Z-0981-2015.