FDA Medical Device Recalls (openFDA)
Sybron Dental Specialties: Herculite Ultra (Part Number 34333), dental composite resorative material. Manufactured by Kerr Corporation, Orange, CA.
- Recall number
- Z-0916-2010
- Recalling firm
- Sybron Dental Specialties
- Product
- Herculite Ultra (Part Number 34333), dental composite resorative material. Manufactured by Kerr Corporation, Orange, CA.
- Status
- Terminated
- Initiated
- 2009-02-23
- Posted
- 2010-03-02
- Terminated
- 2012-03-19
- Reason
- Sybron Dental Specialties is initiating a field correction on the Herculite Ultra, a dental composite restorative material, due to a mistake in the directions for use located in the Herculite technique card.
- Root cause
- Labeling mix-ups
- Action
- Kerr Corporation issued a letter dated February 23, 2009. Users were informed of the affected product and instructed on proper return. For further information, contact Kerr Customer Care at 1-800-537-7123.
- Quantity
- 442
- Distribution
- Nationwide distribution
- Lot, serial or model codes
- Lot Number: 3161098.
- 510(k) numbers
- ["K082671"]
- PMA numbers
- not on file
- Product code
- EBF
- Firm FEI
- 2024312
- Firm city
- Orange
- Firm state
- CA
- 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