FDA Medical Device Recalls (openFDA)
The Straumann Company: Straumann Dental Implant System SP Profile Drill, Short, 0.35mm, WN, L25.0 mm, stainless steel Article No. 044.088
- Recall number
- Z-1035-04
- Recalling firm
- The Straumann Company
- Product
- Straumann Dental Implant System SP Profile Drill, Short, 0.35mm, WN, L25.0 mm, stainless steel Article No. 044.088
- Status
- Terminated
- Initiated
- 2004-05-21
- Posted
- 2004-07-20
- Terminated
- 2004-11-16
- Reason
- Outside label incorrectly identifies drill as Wide Neck (WN) instead of Regular Neck (RN)
- Root cause
- Other
- Action
- Straumann notifed conisignees by letter on May 21,2004 via Fed''X overnight advising of the error on the label states WN instead of RN. The user is advised to that the ID on the article is incorrect.
- Quantity
- 23 units
- Distribution
- Nationwide. AL, AZ, CA, DE, FL, IA, MA, MI. MD, NC, NE, NY, NJ, TX
- Lot, serial or model codes
- Lot: 1215
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DZE
- 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