Z-1035-04

Straumann Dental Implant System SP Profile Drill, Short, 0.35mm, WN, L25.0 mm, stainless steel Article No...

Name: Z-1035-04 Straumann Dental Implant System SP Profile Drill, Short, 0.35mm, WN, L25.0 mm, stainless steel Article No...
Creator: The Straumann Company
Published: 2004-05-21
License: https://open.fda.gov/license/

Straumann USA, LLC / initiated 2004-05-21 / Terminated / root cause: labeling and UDI

FDA source

The Straumann Company began a recall of Straumann Dental Implant System SP Profile Drill, Short, 0.35mm, WN, L25.0 mm, stainless steel Article No. 044.088 on 2004-05-21. The reason FDA records is "Outside label incorrectly identifies drill as Wide Neck (WN) instead of Regular Neck (RN)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1035-04
Status: Terminated
Initiated: 2004-05-21
Posted: 2004-07-20
Terminated: 2004-11-16
Recalling firm: Straumann USA, LLC
Product: Straumann Dental Implant System SP Profile Drill, Short, 0.35mm, WN, L25.0 mm, stainless steel Article No. 044.088
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: Outside label incorrectly identifies drill as Wide Neck (WN) instead of Regular Neck (RN)
Root cause tag: labeling and UDI
FDA 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 in commerce: 23 units
Distribution: Nationwide. AL, AZ, CA, DE, FL, IA, MA, MI. MD, NC, NE, NY, NJ, TX
Product codes and lots: Lot: 1215

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)