Z-1718-2019 Class II Ongoing
FDA device recall Z-1718-2019 was initiated by I.T.S. GmbH on May 9, 2019 and is designated Class II. Reason for recall: The titanium implant has the wrong article number laser marked on it. The recall status is ongoing. Affected quantity: 65 devices.
Recall Details
- Product Type
- Devices
- Report Date
- June 12, 2019
- Initiation Date
- May 9, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 65 devices
Product Description
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 Pattern
Worldwide distribution - US nationwide distribution in the states of Florida and Puerto Rico, and countries of Austria, Netherlands, Slovenia, South Africa, Switzerland.
Code Information
Model Number: 21206-10; Lot Code: 26/F42778