FDA Medical Device Recalls (openFDA)
Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical: NX3 Try-In Gel. The product is used as a tooth shade resin material.
- Recall number
- Z-2259-2013
- Recalling firm
- Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
- Product
- NX3 Try-In Gel. The product is used as a tooth shade resin material.
- Status
- Terminated
- Initiated
- 2013-09-13
- Posted
- 2013-09-19
- Terminated
- 2014-02-11
- Reason
- Kerr Corporation is voluntarily recalling one lot of NX3 Try-In Gel, because some of the NX3 Try-In Gel syringes in the affected lot contain a different product material. The material in the affected syringe does not match the shade of the cement as it is labeled.
- Root cause
- Mixed-up of materials/components
- Action
- Kerr Corporation initiated the voluntary recall by sending out notifications on 09/13/2013 via USPS 1st class mail. The recall notification letter, titled "URGENT: MEDICAL DEVICE RECALL", informed customer of the recall's product description, reason for recall, potential risk, instructions to customers and contact information.
- Quantity
- 197 units
- Distribution
- Worldwide Distribution, including Nationwide in the US and the countries of Canada, Great Britain, Australia, France, Germany, Italy, Denmark, Hong Kong, China, Brazil and Saudi Arabia.
- Lot, serial or model codes
- Part Number 33660. Syringe Lot Number 4580333. Autobag Lot Number 4584609.
- 510(k) numbers
- ["K001899"]
- 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