Recall Z-1179-2018— Keystone Dental Inc

Name: FDA recall Z-1179-2018
Creator: U.S. Food and Drug Administration
Published: 2017-10-16

Class III · Terminated

Class III FDA medical device recall by Keystone Dental Inc, initiated 2017-10-16, terminated 2019-04-17. It names one FDA 510(k) clearance: K072768. Product: STAGE-1¿ RDS COC Abutment Plastic Sleeve, Non-Lock, Multi-Unit; Catalog Number: S2437-01-1K. Reason: A locking plastic abutment sleeve, used by dental technicians in dental laboratories to aid in the creation of the final restorative crown, was packed as a non-locking plastic abutment sleeve..

Recalling firm: Keystone Dental Inc
Classification: Class III
Status: Terminated
Initiated: 2017-10-16
Terminated: 2019-04-17
Firm location: Burlington, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K072768 — RESTORE, STAGE-1, RENOVA PRIMASOLO AND PRIMACONNEX DENTAL IMPLANTSLifecore Biomedical, Inc.·cleared 2007-10-23

K-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 COC Abutment Plastic Sleeve, Non-Lock, Multi-Unit; Catalog Number: S2437-01-1K

Reason for recall

A locking plastic abutment sleeve, used by dental technicians in dental laboratories to aid in the creation of the final restorative crown, was packed as a non-locking plastic abutment sleeve.

Data sourced from openFDA. This site is unofficial and independent of the FDA.