FDA Medical Device Recalls (openFDA)
The Straumann Company: Straumann Dental Implant System, SP Profile Drill, Short, 04.2 mm, RN, L25.0 mm, Stainless steel Ref. Number: 044.084
- Recall number
- Z-0300-05
- Recalling firm
- The Straumann Company
- Product
- Straumann Dental Implant System, SP Profile Drill, Short, 04.2 mm, RN, L25.0 mm, Stainless steel Ref. Number: 044.084
- Status
- Terminated
- Initiated
- 2004-11-11
- Posted
- 2004-12-09
- Terminated
- 2005-02-17
- Reason
- Outside label incorrectly identifes drill as Regular Neck (RN) instead of Wide Neck (WN)
- Root cause
- Other
- Action
- Straumann USA notified users by letter dated 11/11/04 via overnight mail advising users of the label error.
- Quantity
- 85 units
- Distribution
- Nationwide
- Lot, serial or model codes
- Lot Numbers: 1300 and 1301
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NDP
- Firm FEI
- 1000121052
- Firm city
- Waltham
- 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