CLASS II ONGOING Device recall · Reported 1 Jul 2020 · FDA Enforcement Report
Locator Overdenture Implant System Sterile R recalled by Zest Anchors
Zest Anchors is recalling Locator Overdenture Implant System Sterile R, distributed nationwide in the US. The recall was initiated on 22 Nov 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2425-2020
- FDA event ID
- 85369
- Recalling firm
- Zest Anchors, Carlsbad, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Nov 2019
- FDA classified
- 23 Jun 2020
- Reported
- 1 Jul 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Lead & Heavy Metals
- Device type
- Dental Devices
Timeline
| 22 Nov 2019 | Recall initiated by company | |
| 23 Jun 2020 | Classified by FDA | +214 days |
| 1 Jul 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
LOCATOR OVERDENTURE IMPLANT SYSTEM STERILE R Rx Only QTY 1 .
Where it was distributed
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
Nationwide CaliforniaGeorgiaIllinoisKansasMissouriNorth CarolinaNew JerseyOhioOklahomaPuerto RicoVirginiaWashingtonWisconsin
Questions about this recall
Is Locator Overdenture Implant System Sterile R recalled?
Yes. Zest Anchors recalled Locator Overdenture Implant System Sterile R on 22 Nov 2019. The recall is Class II and its status is Ongoing. Recall number Z-2425-2020.
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Zest Anchors
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Locator¿ Implant Attachment System recalled by Zest Anchors | Zest Anchors | Device Malfunction | OH |
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| Device | CLASS II | Grandio Universal Nano-Hybrid Restorative Material recalled | Henry Schein | Packaging Defects | Nationwide |
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| Device | CLASS II | KL Owen Custom Orthodontic Solution recalled by Klowen Braces | Klowen Braces | Device Malfunction | Nationwide |
| Device | CLASS II | Straumann n!ce PMMA Full-arch Restoration recalled | Straumann USA | Other | 8 states |
| Device | CLASS II | Straumann n!ce Zr, HT, Full-arch Restoration recalled | Straumann USA | Other | 8 states |