LOCATOR OVERDENTURE IMPLANT SYSTEM STERILE R Rx Only QTY 1 .
Reported: July 1, 2020 Initiated: November 22, 2019 #Z-2425-2020
Product Description
LOCATOR OVERDENTURE IMPLANT SYSTEM STERILE R Rx Only QTY 1 .
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.
Details
- Recalling Firm
- Zest Anchors LLC
- Units Affected
- 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
- Location
- Carlsbad, CA
Frequently Asked Questions
What product was recalled? ▼
LOCATOR OVERDENTURE IMPLANT SYSTEM STERILE R Rx Only QTY 1 .. Recalled by Zest Anchors LLC. Units affected: 154 kits.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on July 1, 2020. Severity: Moderate. Recall number: Z-2425-2020.
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