Z-0089-2019 Class II Terminated

Recalled by Implant Direct Sybron Manufacturing, LLC — Thousand Oaks, CA

Recall Details

Product Type
Devices
Report Date
October 17, 2018
Initiation Date
May 29, 2018
Termination Date
July 29, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
217 units

Product Description

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 Pattern

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

Code Information

Part number 8735-05, Lot number 90212