FDA Medical Device Recalls (openFDA)
Straumann USA LLC: Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;
- Recall number
- Z-0582-2026
- Recalling firm
- Straumann USA LLC
- Product
- Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;
- Status
- Open, Classified
- Initiated
- 2025-10-17
- Posted
- 2025-11-21
- Terminated
- not on file
- Reason
- The possibility for this product that is intended for demonstration purposes only to be placed in patients.
- Root cause
- Under Investigation by firm
- Action
- On October 17, 2025 Urgent Field Safety Action letters were sent to customers. Action to be taken: 1. 1. Check your inventory for the affected article/lot numbers. If the article is still in your inventory, then stop use/ distribution of the product immediately and quarantine / segregate physically. Please return the affected items to the attention of Jennifer Jackson at Straumann USA, LLC for credit as indicated on the Customer Confirmation Form. 2. 2. In all cases, complete and return the enclosed Customer Confirmation Form with the affected product using the return UPS label provided. Transmission of the Field Safety Notice This notice needs to be passed on to all those who need to be aware within your organization or to any organization where the affected devices have been transferred. The Food and Drug Administration (FDA) has been informed about this Field Safety Corrective Action. We apologize for any inconvenience that this may cause.
- Quantity
- 61 units
- Distribution
- US Nationwide distribution in the states of AZ, CA, DE, FL, ID, MO, TN, TX, UT, VA.
- Lot, serial or model codes
- 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;
- 510(k) numbers
- not on file
- PMA numbers
- ["P930021"]
- Product code
- NQA
- Firm FEI
- 1000121052
- Firm city
- Andover
- 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