Z-0981-2015 Class II Terminated
FDA device recall Z-0981-2015 was initiated by Straumann USA, LLC on October 27, 2014 and is designated Class II. Reason for recall: Drill set may contain incorrect drill. The recall status is terminated (terminated April 10, 2015). Affected quantity: 362 pieces.
Recall Details
- Product Type
- Devices
- Report Date
- January 21, 2015
- Initiation Date
- October 27, 2014
- Termination Date
- April 10, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 362 pieces
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.
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.
Code Information
Lot Numbers: GY037, HA443, HE874, HL216