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U.S. Department of Health and Human Services

Class 3 Device Recall K3 Engine File GPack

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  Class 3 Device Recall K3 Engine File GPack see related information
Date Initiated by Firm August 01, 2008
Date Posted March 06, 2012
Recall Status1 Terminated 3 on March 08, 2012
Recall Number Z-1172-2012
Recall Event ID 61224
Product Classification File, pulp canal, endodontic - Product Code EKS
Product K3 Engine File G-Pack,
Product: Endodontic Pulp Canal File, Part Number: 830-9925.

For use in root canal preparation.
Code Information Lot Number: 08E182E.
Recalling Firm/
Manufacturer		 Ormco Corporation
1332 S Lone Hill Ave
Glendora CA 91740
For Additional Information Contact
909-962-5600
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 199 units
Distribution Worldwide Distribution -- US, including the territory of St. Thomas, and countries of Australia, Canada, New Zealand, China, Singapore, India, and Chile.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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