Recall Z-1861-2025— Straumann USA LLC
Class II · Ongoing
Class II FDA medical device recall by Straumann USA LLC, initiated 2025-04-14. FDA's recall record names no specific 510(k) clearance for this event. Product: Plus Initial Drill, Article Number: 103.170;. Reason: The referred batch was produced without the laser engraving of 7 mm..
- Recalling firm
- Straumann USA LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-04-14
- Firm location
- Andover, MA, United States
Product description
Plus Initial Drill, Article Number: 103.170;
Reason for recall
The referred batch was produced without the laser engraving of 7 mm.
Data sourced from openFDA. This site is unofficial and independent of the FDA.