Recall Z-0981-2015
Straumann USA, LLC · initiated October 27, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Drill set long, drill stop compatible for 4.8mm diameter implant, Article Number 040.447S Endosseous dental implant drill set.
Codes / lots: Lot Numbers: GY037, HA443, HE874, HL216
Reason for recall
Drill set may contain incorrect drill.
FDA-determined 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.
Details
- Recall number
- Z-0981-2015
- Initiated
- October 27, 2014
- Posted by FDA
- January 15, 2015
- Terminated
- April 10, 2015
- Product code
- NDP – Accessories, Implant, Dental, Endosseous
- Quantity
- 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.
- Recalling firm
- Straumann USA, LLC, Andover, MA