Z-0582-2026 Class II Ongoing
FDA device recall Z-0582-2026 was initiated by Straumann USA LLC on October 17, 2025 and is designated Class II. Reason for recall: The possibility for this product that is intended for demonstration purposes only to be placed in patients. The recall status is ongoing. Affected quantity: 61 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 3, 2025
- Initiation Date
- October 17, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 61 units
Product Description
Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;
Reason for Recall
The possibility for this product that is intended for demonstration purposes only to be placed in patients.
Distribution Pattern
US Nationwide distribution in the states of AZ, CA, DE, FL, ID, MO, TN, TX, UT, VA.
Code Information
1. Article Number: 440.230V10; UDI-DI: N/A; Lot Numbers: EPZM8, HPT6, KEWN9, NAAM6, VAW80; 2. Article Number: 475.132V10; UDI-DI: N/A; Lot Numbers: CRL56, HPHJ1;