LOCATOR 01940Recalls & reported problems
Zest Anchors, LLC · LOCATOR Abutment for I-KONE 5.0mm Cuff, Tekka · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840481100277), received between Jun 4, 2021 and Jun 4, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Hypersensitivity/Allergic reaction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 4, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
ACCOUNT REPORTED THAT CUSTOMER COMPLAINED ABOUT AN ALLERGY TO THE ABUTMENTS. ZEST EVALUATION: THERE IS NO PRODUCT EXPERIENCE REPORTED AS FOR ALLERGIC REACTIONS CAUSED BY THE USE OF ZEST ABUTMENTS. THE ZEST ABUTMENT PRODUCT DOES NOT CONTAIN NICKEL; THEREFORE, THE PATIENT COULD NOT HAVE AN ALLERGIC REACTION FROM THE ABUTMENTS. NO PHYSICAL EVALUATION CAN BE PERFORMED AS PRODUCT WAS NOT RETURNED. ZEST WAS UNABLE TO FIND EVIDENCE OF A MANUFACTURING ISSUE PER CURRENT RECORDS, AND BELIEVES THAT THE COMPONENTS DO NOT PRESENT ANY MANUFACTURER ERRORS.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 11942622 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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