FDA recall Z-0727-2018

Product

Stage-1¿ RDS Indexed Abutment for RDS Stage-1¿ Single Stage Implants Keystone s implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations and terminal or intermediate abutment support for fixed bridgework.

Reason for recall

The recalled units are mislabeled with an incorrect expiration date. The expiration date printed on the label is 2202-06. The correct expiration date should be 2022-06.

Distribution

Nationally.

Key facts

Status

Terminated

Initiation date

2017-08-25

Report date

2018-03-07

Termination date

2019-04-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Burlington, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0727-2018