Tapered Screw-Vent MTX recalled over labeling errors

Recall date

November 29, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Zimmer Dental Inc recalls Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSV4B10.

Recall number

Z-1190-2018

FDA classification

Class II

Brand / firm

Zimmer Dental Inc

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSV4B10.