Southern Implants, Inc recalls MAX-TL 9.0 x 7.0 mm Implant, Catalog No. 15711K; Z-MAX Implant 9.0 x 7 mm Length, Catalog No. Z-MAX9-7. Dental implant.…

Recall date

January 23, 2015

Source

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

Recall number

Z-1265-2015

FDA classification

Class II

Brand / firm

Southern Implants, Inc

Sold / distributed

US Nationwide Distribution.

Why it was recalled

Z-MAX Implant, 9mm diameter, 7mm length labeled package, catalog number Z-MAX9-7, contained a MAX-TL Implant, 9mm diameter, 7mm length. And vice versa.

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

What was recalled

MAX-TL 9.0 x 7.0 mm Implant, Catalog No. 15711K; Z-MAX Implant 9.0 x 7 mm Length, Catalog No. Z-MAX9-7. Dental implant. Product Usage: The MAX Implant is intended to be implanted in the upper and lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses.