Carlsbad, CA, United States
Zest Anchors LLC recalls
1 recall recorded since 2018, most recently on 22 November 2019. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 22 November 2019
- 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.
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2425-2020
- LOCATOR OVERDENTURE IMPLANT SYSTEM STERILE R Rx Only QTY 1 .
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.