K3 Engine File G-Pack, Product: Endodontic Pulp Canal File, Part Number: 830-9925. For use in root canal preparation.
FDA device recall Z-1172-2012 · posted 2012-03-06 · Terminated
Recall details
- Recalling firm
- Ormco Corporation
- Reason for recall
- A recall was initiated because SybronEndo has confirmed that the K3 Engine File G-Pack has label packaging and file mis-marking error.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- EKS
- Quantity affected
- 199 units
- Distribution
- Worldwide Distribution -- US, including the territory of St. Thomas, and countries of Australia, Canada, New Zealand, China, Singapore, India, and Chile.
- Date initiated
- 2008-08-01
- Date posted
- 2012-03-06
- Date terminated
- 2012-03-08
- Location
- Glendora, CA
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