FDA Medical Device Recalls (openFDA)
Straumann USA, LLC: Drill set long, drill stop compatible for 4.8mm diameter implant, Article Number 040.447S Endosseous dental implant drill set.
- Recall number
- Z-0981-2015
- Recalling firm
- Straumann USA, LLC
- Product
- Drill set long, drill stop compatible for 4.8mm diameter implant, Article Number 040.447S Endosseous dental implant drill set.
- Status
- Terminated
- Initiated
- 2014-10-27
- Posted
- 2015-01-15
- Terminated
- 2015-04-10
- Reason
- Drill set may contain incorrect drill.
- Root cause
- Process control
- Action
- 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.
- 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.
- Lot, serial or model codes
- Lot Numbers: GY037, HA443, HE874, HL216
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NDP
- Firm FEI
- 1000121052
- Firm city
- Andover
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28