FDA Medical Device Recalls (openFDA)
Ormco Corporation: K3 Engine File G-Pack, Product: Endodontic Pulp Canal File, Part Number: 830-9925. For use in root canal preparation.
- Recall number
- Z-1172-2012
- Recalling firm
- Ormco Corporation
- Product
- K3 Engine File G-Pack, Product: Endodontic Pulp Canal File, Part Number: 830-9925. For use in root canal preparation.
- Status
- Terminated
- Initiated
- 2008-08-01
- Posted
- 2012-03-06
- Terminated
- 2012-03-08
- Reason
- A recall was initiated because SybronEndo has confirmed that the K3 Engine File G-Pack has label packaging and file mis-marking error.
- Root cause
- Process control
- Action
- A recall communication was initiated on 07/31/2008 with SybronEndo forwarding an Urgent Medical Device Recall letter (via USPS 1st class mail) to all their customers who purchased the K3 Engine File G-Pack (Part No. 830-9925). The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to contact SybronEndo Customer Care at (800) 346-3636 directly to handle the arrangements of a quick return and replacement. Customers were instructed to complete the Return Form and return any affected product in their inventory.
- Quantity
- 199 units
- Distribution
- Worldwide Distribution -- US, including the territory of St. Thomas, and countries of Australia, Canada, New Zealand, China, Singapore, India, and Chile.
- Lot, serial or model codes
- Lot Number: 08E182E.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- EKS
- Firm FEI
- 2016150
- Firm city
- Glendora
- 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