FDA recall Z-1167-2018

Implant Direct Sybron Manufacturing, LLC · Class II · device

Product

SwishTapered Implant Intended for use in support for fixed bridgework.

Reason for recall

The extender that is packaged with the SwishTapered" and SwishPlus" Implant may have been packaged in the incorrect position (upside down in the plastic retainer).

Distribution

Worldwide Distribution -- US, Europe, Canada, Australia, and Japan.

Key facts

Status: Terminated
Initiation date: 2018-01-19
Report date: 2018-03-28
Termination date: 2023-07-26
Voluntary/Mandated: Voluntary: Firm initiated
Location: Westlake Village, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1167-2018