I.T.S. GmbH recalls Rim Plate, 10-Hole, Left, PRS RX System. Titanium, implantable - Product Usage: The implant temporarily stabilizes bone…

Recall date

May 9, 2019

Source

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

Recall number

Z-1718-2019

FDA classification

Class II

Brand / firm

I.T.S. GmbH

Sold / distributed

Worldwide distribution - US nationwide distribution in the states of Florida and Puerto Rico, and countries of Austria, Netherlands, Slovenia, South Africa, Switzerland.

Why it was recalled

The titanium implant has the wrong article number laser marked on it.

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

What was recalled

Rim Plate, 10-Hole, Left, PRS RX System. Titanium, implantable - Product Usage: The implant temporarily stabilizes bone segments until bony consolidation has taken place. After this, the implant has no more use and can be removed.