Zimmer Dental Inc recalls Zimmer Dental Tapered SwissPlus & SwissPlus Implant Systems surgical kit, Ref OPCST. The label shows the product is Man…

Recall date

October 11, 2017

Source

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

Recall number

Z-0280-2018

FDA classification

Class II

Brand / firm

Zimmer Dental Inc

Sold / distributed

Worldwide Distribution: US (nationwide) and countries of: Canada, Australia, Belgium, Bulgaria, Chile, Costa Rica, Egypt, France, Georgia, Germany, Hong Kong, Hungary, Iran, Ireland, Israel, Italy, Japan, Lebanon, Lithuania, Netherlands, Nicaragua, Poland, Portugal, Romania, Serbia, Shanghai, Spain…

Why it was recalled

The device may contain a manufacturing condition affecting the geometry of the driver's hex feature which prevents it from properly engaging the fixture mount transfer and/or a dental implant.

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

What was recalled

Zimmer Dental Tapered SwissPlus & SwissPlus Implant Systems surgical kit, Ref OPCST. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA. Endosseous dental implant accessories are manually powered devices intended to aid in the placement or removal of endosseous dental implants and abutments, prepare the site for placement of endosseous dental implants or abutments, aid in the fitting of endosseous dental implants or abutments, aid in the fabrication of dental prosthetics, and be used as an accessory with endosseous dental implants when tissue contact will last less than 1 hour.