FDA recall Z-0089-2019

Product

Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Platform. Dental implant component, used temporarily during impressions for the prosthetic procedure.

Reason for recall

Cap may be mislabeled with incorrect part number, although the correct part number is on the main vial label.

Distribution

Worldwide distribution. US nationwide, Canada, Germany, Great Britain, Kuwait, Lithuania, Monaco, Netherlands, and Slovakia.

Key facts

Status

Terminated

Initiation date

2018-05-29

Report date

2018-10-17

Termination date

2020-07-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Thousand Oaks, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0089-2019