FDA recall Z-1189-2018

Product

Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSVTB10.

Reason for recall

Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvertently commingled during the manufacturing process and may be mislabeled.

Distribution

Worldwide distribution US nationwide, Canada, Chile, Costa Rica, Denmark, France, Hungary, Italy, Japan, Lebanon, Portugal, Serbia, Spain, and Taiwan.

Key facts

Status

Terminated

Initiation date

2017-11-29

Report date

2018-04-04

Termination date

2019-02-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Carlsbad, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1189-2018