—#131491

Product

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

FDA product code: NDP — Accessories, Implant, Dental, Endosseous
Device class: Class 1
Medical specialty: Dental
Affected lot / code info: Lot Numbers: GY037, HA443, HE874, HL216

Why it was recalled

Drill set may contain incorrect drill.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Straumann USA, LLC
Address: 60 Minuteman Rd, Andover, Massachusetts 01810-1008

Distribution

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.

Timeline

Recall initiated: 2014-10-27
Posted by FDA: 2015-01-15
Terminated: 2015-04-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #131491. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.