Z-1876-2008

Straumann Handpiece Driver for RN Solid Abutment 6 L 26.0mm,Stainless Steel -- Reference Number: 80426...

Name: Z-1876-2008 Straumann Handpiece Driver for RN Solid Abutment 6 L 26.0mm,Stainless Steel -- Reference Number: 80426...
Creator: Straumann Manufacturing Inc.
Published: 2008-05-28
License: https://open.fda.gov/license/

Straumann USA, LLC / initiated 2008-05-28 / Terminated / root cause: manufacturing process

FDA source

Straumann Manufacturing Inc. began a recall of Straumann Handpiece Driver for RN Solid Abutment 6 L 26.0mm,Stainless Steel -- Reference Number: 80426. Product is intended as radiographic guides and surgical... on 2008-05-28. The reason FDA records is "Handpiece driver is out of specification and will not function with the dental solid abutment. Possible risks involved include: inconvenience to patient and the need to reschedule surgery or proceed without the device". 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-1876-2008
Status: Terminated
Initiated: 2008-05-28
Posted: 2008-09-16
Terminated: 2009-11-06
Recalling firm: Straumann USA, LLC
Product: Straumann Handpiece Driver for RN Solid Abutment 6 L 26.0mm,Stainless Steel -- Reference Number: 80426. Product is intended as radiographic guides and surgical templates for the initial placement of the 2.2 mm pilot drill used in the site preparation for the placement of Straumann dental implants.
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: Handpiece driver is out of specification and will not function with the dental solid abutment. Possible risks involved include: inconvenience to patient and the need to reschedule surgery or proceed without the device.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On May 28, 2008, Straumann issued an Urgent Device Recall and a Recall Acknowledgement Form to its consignees via Fed Ex. Accounts are requested to return product and a replacement or credit will issue. If you have any questions contact Bernie McDonald at (978) 747-2514.
Quantity in commerce: 129 units
Distribution: Class III Recall - Nationwide Distribution.
Product codes and lots: Lot Number: C4724

Product code DZE

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)