Recall Z-0727-2018— Keystone Dental Inc
Class II · Terminated
Class II FDA medical device recall by Keystone Dental Inc, initiated 2017-08-25, terminated 2019-04-16. It names one FDA 510(k) clearance: K072768. 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: 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..
- Recalling firm
- Keystone Dental Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-08-25
- Terminated
- 2019-04-16
- Firm location
- Burlington, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.