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Recall Observatory FDA recall evidence

Device product

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

Z-0981-2015

October 27, 2014

Class II

Product summary

Firm
Straumann USA, LLC
Event
Event 69767
Status
Terminated
Classification
Class II
Quantity
362 pieces
Official record key
device-enforcement:Z-0981-2015

Official wording

Reason: Drill set may contain incorrect drill.

Code information: Lot Numbers: GY037, HA443, HE874, HL216

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Drill set may contain incorrect drill.