Agency classClass IIOur severity:High FDA (Devices)·Z-2425-2020·Announced 2020-07-01

Zest Anchors Recalls Locator Overdenture Implant Systems Due to Abutment Defects

Zest Anchors LLC is recalling Locator Overdenture Implant Systems because the abutments may be out of specification, potentially causing a gap between the implant and abutment.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a structural defect in a medical device that could lead to a gap in the patient, representing a risk of harm where injury has not yet been reported.

Plain-English summary

Zest Anchors LLC is recalling 154 kits of Locator Overdenture Implant Systems. The recall involves specific lots of implants with dimensions including 2.4mmD x 12mmL, 2.9mmD x 10mmL, 2.9mmD x 14mmL, and 3.4mmD x 12mmL. The affected products were distributed nationwide in the United States, including in Wisconsin, Virginia, Ohio, Illinois, Georgia, North Carolina, Kansas, New Jersey, California, Washington, Oklahoma, Missouri, and Puerto Rico, as well as in Switzerland, Germany, Mexico, Poland, and Thailand.

The recall was initiated because the abutment provided with the implant system may be out of specification. This defect could lead to a small gap occurring between the implant and the abutment during assembly in the patient. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Healthcare providers and patients should check their inventory and patient records for the specific lot numbers and UDI numbers listed in the recall notice. If the affected products have been implanted, providers should contact Zest Anchors LLC for further instructions on management and potential replacement.

The recalled product

Product: LOCATOR OVERDENTURE IMPLANT SYSTEM STERILE R Rx Only QTY 1 .
Manufacturer: Zest Anchors LLC
Category: Medical Device — Dental Implants
Hazard: structural-defect
implant-failure
Affected units: 154

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (14)

2.4mmD x 12mmL
2.5mm Cuff 07451 Lot # L17MB
UDI Number: 00840481101496 LOCATOR Overdenture Implant
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
3.4mmD x 12mmL
4mm Cuff 07476 Lot # L17VE
UDI Number: 00840481126116

Distribution

Distributed nationwide across the United States.

The notice also names 13 states specifically:

Same manufacturer · Zest Anchors LLC

See all →

Moderate
Zest Anchors Recalls Locator Implant Attachment Systems Due to Labeling Error
FDA (Devices) · 2014-02-12

Same hazard · structural defect