FDA recall Z-2425-2020

Product

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.

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

Key facts

Status

Ongoing

Initiation date

2019-11-22

Report date

2020-07-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Carlsbad, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2425-2020