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

FDA device recall Z-0981-2015 · posted 2015-01-15 · Terminated

Recall details

Recalling firm

Straumann USA, LLC

Reason for recall

Drill set may contain incorrect drill.

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.

Root cause

Process control

Status

Terminated

Product code

NDP

Quantity affected

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

Date initiated

2014-10-27

Date posted

2015-01-15

Date terminated

2015-04-10

Location

Andover, MA