FDA recall Z-1179-2018

Product

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.

Distribution

International Distribution to: Germany only.

Key facts

Status

Terminated

Initiation date

2017-10-16

Report date

2018-04-04

Termination date

2019-04-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Burlington, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1179-2018