Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Straumann Dental Implant System, SP Profile Drill, Short, 04.2 mm, RN, L25.0 mm, Stainless steel Ref. Number: 044.084

FDA Recall Z-0300-05 · Posted 2004-12-09

Recalling FirmThe Straumann Company
Recall StatusTerminated
Product CodeNDP
Date Initiated2004-11-11
Date Terminated2005-02-17
Product Quantity85 units

Reason for Recall

Outside label incorrectly identifes drill as Regular Neck (RN) instead of Wide Neck (WN)

Firm Action

Straumann USA notified users by letter dated 11/11/04 via overnight mail advising users of the label error.

Root Cause

Other

Distribution Pattern

Nationwide

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑