FDA Device recall Z-1718-2019
Rim Plate, 10-Hole, Left, PRS RX System
- FDA Device
- Class II
- ongoing
- Published 2019-06-12
On 2019-06-12 the FDA classified a Class II recall of Rim Plate, 10-Hole, Left, PRS RX System by I T S, citing the titanium implant has the wrong article number laser marked on it.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1718-2019 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-05-09 |
| Published | 2019-06-12 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | I T S |
| Distribution | US |
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
The titanium implant has the wrong article number laser marked on it.
Identifiers
| code_info | Model Number: 21206-10; Lot Code: 26/F42778 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1718-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.