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.
Z-1718-2019
Product summary
- Firm
- I.T.S. GmbH
- Event
- Event 82796
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 65 devices
- Official record key
device-enforcement:Z-1718-2019
Official wording
Reason: The titanium implant has the wrong article number laser marked on it.
Code information: Model Number: 21206-10; Lot Code: 26/F42778
Distribution pattern: Worldwide distribution - US nationwide distribution in the states of Florida and Puerto Rico, and countries of Austria, Netherlands, Slovenia, South Africa, Switzerland.
Derived failure modes
-
Unknown
The titanium implant has the wrong article number laser marked on it.