Class II — I.T.S. GmbH
| Recalling firm | I.T.S. GmbH |
|---|---|
| Registered facility | I.T.S. GMBH (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | The titanium implant has the wrong article number laser marked on it. |
| 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. |
| Quantity | 65 devices |
| Distribution | Worldwide distribution - US nationwide distribution in the states of Florida and Puerto Rico, and countries of Austria, Netherlands, Slovenia, South Africa, Switzerland. |
| Initiated | 2019-05-09 |
| Classified | 2019-06-04 |
| Recall number | Z-1718-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — I.T.S. GmbH (Z-1718-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/82796/
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