FDA-Device2019-06-12Class II
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.
I.T.S. GmbH
Hazard
The titanium implant has the wrong article number laser marked on it.
Sold states
Worldwide distribution - US nationwide distribution in the states of Florida and Puerto Rico, and countries of Austria, Netherlands, Slovenia, South Africa, Switzerland.
Affected count
65 devices
Manufactured in
Autal 28, Lasnitzhohe, Austria
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1718-2019Don't want to check this manually?
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