Drill set long, drill stop compatible for 4.8mm diameter implant, Article Number 040.447S Endosseous dental implant drill set.
This recall has been terminated (originally issued January 15, 2015).
- Company
- Straumann Usa Llc
- Recall Initiated
- October 27, 2014
- Posted
- January 15, 2015
- Terminated
- April 10, 2015
- Recall Number
- Z-0981-2015
- Quantity
- 362 pieces
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Drill set may contain incorrect drill.
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.
Lot / Code Info
Lot Numbers: GY037, HA443, HE874, HL216
Root Cause
Process control
Action Taken
Straumann sent a Field Safety Corrective Action by letter dated October 29, 2014 which was delivered via United Parcel Service. The letter identified the product the problem and the action needed to be taken by the customer. Customers are asked to examine their inventory and return the product. In addition, customers are asked to complete a Customer Confirmation Form and return it to Straumann via fax to (978)747-0023.