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I.T.S. GmbH recalls Rim Plate, 10-Hole, Left, PRS RX System. Titanium, implantable - Product Usage: The implant temporarily stabilizes bone
Recalled June 12, 2019 · FDA recall Z-1718-2019 · I.T.S
Hazard
The titanium implant has the wrong article number laser marked on it. · FDA Class II
Units
65 devices
Sold at
Worldwide distribution - US nationwide distribution in the states of Florida and Puerto Rico, and countries of Austria, Netherlands, Slovenia, South Africa, Switzerland.
Description
The titanium implant has the wrong article number laser marked on it.
Product
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.
Manufacturer(s)
I.T.S. GmbH
Made in
Austria
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →