FDA recall Z-1718-2019

I.T.S. GmbH · Class II · device

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.

Reason for recall

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

Distribution

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

Key facts

Status
Ongoing
Initiation date
2019-05-09
Report date
2019-06-12
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lasnitzhohe, Austria

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1718-2019