Zimmer Dental Inc recalls GemLock Long Hex Driver, Catalog RHL2.5; Also distributed within the Tapered SwissPlus & SwissPlus Implant Systems Kits…

Recall date

January 22, 2015

Source

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

Recall number

Z-1115-2015

FDA classification

Class II

Brand / firm

Zimmer Dental Inc

Sold / distributed

Worldwide Distribution -- US, Argentina, Australia, Bulgaria, Canada, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, Egypt, France, Germany, Hong Kong, Hungary, Iran, Israel, Italy, Japan, Lebanon, Lithuania, Malaysia, Mexico, Morocco, Netherlands, Pakistan, Panama, Poland, Romania, Russ…

Why it was recalled

The Gemlock Long Hex Driver may not fit into the Fixture Mount Transfer (FMT) or the internal hex of the 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

GemLock Long Hex Driver, Catalog RHL2.5; Also distributed within the Tapered SwissPlus & SwissPlus Implant Systems Kits, Surgical, Complete, Catalog OPCST; Tapered Screw-Vent Implant System Surgical Kit, Complete, Catalog TSVKIT. Used as a manual delivery tool that engages the Fixture Mount Transfer (FMT) to transport the dental implant from the product packaging to the osteotomy.