Z-0981-2015Class II

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

Name: Z-0981-2015 Drill set long, drill stop compatible for 4.8mm diameter implant, Article Number 040.447S Endosseous dental...
Creator: Straumann USA, LLC
Published: 2014-10-27
License: https://open.fda.gov/license/

Straumann USA, LLC / initiated 2014-10-27 / Terminated / root cause: manufacturing process

FDA source

Straumann USA, LLC began a recall of Drill set long, drill stop compatible for 4.8mm diameter implant, Article Number 040.447S Endosseous dental implant drill set on 2014-10-27. FDA classified it as Class II and gives the reason as "Drill set may contain incorrect drill". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0981-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-27
Posted: 2015-01-15
Terminated: 2015-04-10
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.
Product code: NDP Accessories, Implant, Dental, Endosseous
Reason for recall: Drill set may contain incorrect drill.
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: Lot Numbers: GY037, HA443, HE874, HL216

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0981-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0981-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-21	2015-01-15

Product code NDP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)