Ormco Corporation K3 Engine File G-Pack, Product: Endodontic Pulp Canal File, Part Number: 830-9925. For use in root canal preparation. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
K3 Engine File G-Pack, Product: Endodontic Pulp Canal File, Part Number: 830-9925. For use in root canal preparation.
Brand
Ormco Corporation
Lot Codes / Batch Numbers
Lot Number: 08E182E.
Products Sold
Lot Number: 08E182E.
Ormco Corporation is recalling K3 Engine File G-Pack, Product: Endodontic Pulp Canal File, Part Number: 830-9925. For use in root due to A recall was initiated because SybronEndo has confirmed that the K3 Engine File G-Pack has label packaging and file mis-marking error.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A recall was initiated because SybronEndo has confirmed that the K3 Engine File G-Pack has label packaging and file mis-marking error.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026