Rim Plate — Class II medical device recall Z-1718-2019
Ongoing recall by I.T.S. GmbH, reported 2019-06-12, distributed nationwide. The titanium implant has the wrong article number laser marked on it.
| Recall number | Z-1718-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | I.T.S. GmbH, Lasnitzhohe, Austria |
| Recall initiated | 2019-05-09 |
| Classified | 2019-06-04 |
| Reported by FDA | 2019-06-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, CH, NL, SI, ZA |
| Quantity | 65 devices |
| Lot numbers | 26/F42778 |
| Model numbers | 21206-10 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1718-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.