Keystone Dental Inc recalls STAGE-1¿ RDS COC Abutment Plastic Sleeve, Non-Lock, Multi-Unit; Catalog Number: S2437-01-1K

Recall date

October 16, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1179-2018

FDA classification

Class III

Brand / firm

Keystone Dental Inc

Sold / distributed

International Distribution to: Germany only.

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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