Zest Anchors LLC: LOCATOR OVERDENTURE IMPLANT SYSTEM STERILE R Rx Only QTY 1 .

Recall number

Z-2425-2020

Recalling firm

Zest Anchors LLC

Product

LOCATOR OVERDENTURE IMPLANT SYSTEM STERILE R Rx Only QTY 1 .

Status

Open, Classified

Initiated

2019-11-22

Posted

not on file

Terminated

not on file

Reason

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.

Root cause

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

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

Lot, serial or model codes

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

510(k) numbers

["K120198"]

PMA numbers

not on file

Product code

DZE

Firm FEI

2023950

Firm city

Carlsbad

Firm state

CA

Firm country

not on file

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

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