Device 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.
Z-0727-2018
Product summary
- Event
- Event 79110
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20
- Official record key
device-enforcement:Z-0727-2018
Official wording
Reason: 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.
Code information: Catalog# S2400K, Lot 34276
Distribution pattern: Nationally.
Derived failure modes
-
Labeling or packaging
mislabeled