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U.S. Department of Health and Human Services

Class 2 Device Recall LOCATOR Overdenture Implant System

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  Class 2 Device Recall LOCATOR Overdenture Implant System see related information
Date Initiated by Firm November 22, 2019
Create Date June 24, 2020
Recall Status1 Open3, Classified
Recall Number Z-2425-2020
Recall Event ID 85369
510(K)Number K120198  
Product Classification Implant, endosseous, root-form - Product Code DZE
Product LOCATOR OVERDENTURE IMPLANT SYSTEM STERILE R Rx Only QTY 1 .
Code Information The UDI number for the affected lots are as follows:  Product Name Part #  LOCATOR Overdenture Implant, 2.4mmD x 12mmL,2.5mm Cuff 07451 Lot # L17MB; UDI Number: 00840481101496  LOCATOR Overdenture Implant, 2.4mmD x 12mmL, 4mm Cuff 07456 Lot # Ll5PB; L166F; UDI Number: 00840481101526  LOCATOR Overdenture Implant, 2.9mmD x 10mmL, 4mm Cuff 07465 Lot # L15H7; L15H9; UDI Number: 00840481101571  LOCATOR Overdenture Implant, 2.9mmD x 14mmL, 4mm Cuff 07467 Lot # USHA UDI Number: 00840481101595  LOCATOR Overdenture Implant, 3.4mmD x 12mmL, 4mm Cuff 07476 Lot # L17VE; UDI Number: 00840481126116   
Recalling Firm/
Manufacturer		 Zest Anchors LLC
2875 Loker Ave E
Carlsbad CA 92010-6626
For Additional Information Contact Mark Stavro
760-743-7744
Manufacturer Reason
for Recall		 The abutment provided with the Implant System may be out of specification, which could lead to a small gap occurring between the implant and abutment on assembly in the patient.
FDA Determined
Cause 2		 Process control
Action The firm initially contacted their customers by phone between 11/20-22/2019 and then sent out Customer Notification Letters on 11/22/2019 via email. The Customer Notification Letter is informing customers: The firm has determined that the abutment provided with the Implant System may be out of specification, which could lead to a small gap occurring between the implant and abutment on assembly in the patient. The potential gap between the implant and the abutment could result in a space for bacteria to potentially harbor and grow, which could lead to an increase in future infection risk. To mitigate this risk, the abutment should be replaced without removing the implant. If this action is taken, the abutment z-position may be lowered, and the denture as originally "picked-up" may result in a sub-optimal denture fit (i.e., exerting additional force on the tissue). In this situation, the clinician/patient will need to re-evaluate the denture fit. If needed, the denture may be re-aligned per standard practice to return the denture to optimal fit. Customer are requested to: -Separate and quarantine any of the affected products that are currently in their inventory and return them to the Recalling Firm. -Complete, sign and return the Acknowledgement & Receipt Forms and email to mark.stavro@zestdent.com. -Ask the healthcare professionals (end users) to return products. In additional, customer are being informed: -If the implant and abutment have not been used: 1. Separate and quarantine any of the affected product that are currently in their inventory. 2. If the product has been further distributed, notify customers and retrieve, as appropriate. 3. Return affected product for a free of charge replacement. -If the implant has been placed, contact the Recalling Firm at 800-262-2310 for recommended actions and replacement product dependent upon the following circumstance: 1. Implant has been placed, but not restored: The Recalling Firm do
Quantity in Commerce 154 kits
Distribution US Nationwide Distribution in the state of: WI; VA; OH; IL; GA; NC; KS; NJ; CA; WA; OK; MO and Puerto Rico OUS: Switzerland, Germany, Mexico, Poland, and Thailand
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DZE and Original Applicant = ZEST ANCHORS, LLC
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