FDA Medical Device Recalls (openFDA)
Straumann Manufacturing Inc.: 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.
- Recall number
- Z-1876-2008
- Recalling firm
- Straumann Manufacturing Inc.
- 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.
- Status
- Terminated
- Initiated
- 2008-05-28
- Posted
- 2008-09-16
- Terminated
- 2009-11-06
- Reason
- 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
- 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
- 129 units
- Distribution
- Class III Recall - Nationwide Distribution.
- Lot, serial or model codes
- Lot Number: C4724
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DZE
- 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