I — Class II medical device recall Z-1601-2026
Ongoing recall by I.T.S. GmbH, reported 2026-04-01, distributed nationwide. Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions t
| Recall number | Z-1601-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | I.T.S. GmbH, Lasnitzhohe, Austria |
| Recall initiated | 2026-01-23 |
| Classified | 2026-03-20 |
| Reported by FDA | 2026-04-01 |
| Distributed | Nationwide (US) |
| Quantity | 869 units |
| Lot numbers | 21225-10, 21225-12, 21225-4, 21225-6, 21225-8, 21226-10, 21226-12, 21226-4, 21226-6, 21226-8, 21601-10, 21601-12, 21601-14, 21601-16, 21601-5, 21601-6, 21601-7, 21601-8, 21602-3, 21602-4, 21602-5, 21602-6, 21602-7, 21602-8, 21603-3, 21603-4, 21603-5, 21603-6, 21603-7, 21603-8, 26/F65041, 26/F65042, 26/F65044, 26/F65635, 26/F66149, 26/F66150, 26/F66152, 26/F66499, 26/F66500, 26/F66501 and 33 more |
Product
I.T.S. Fibula Plate PROlock with Angular Stability with the below descriptions and corresponding article numbers. 1. Distal Tubular Plate; Article Numbers: 21602-3, 21602-4, 21602-5, 21602-6, 21602-7, 21602-8, 21603-3, 21603-4, 21603-5, 21603-6, 21603-7, 21603-8. 2. Fibula Plate 3.5mm; Article Numbers: 21225-4, 21225-6, 21225-8, 21225-10, 21225-12, 21226-4, 21226-6, 21226-8, 21226-10, 21226-12. 3. Universal Tubular Plate; Article Numbers: 21601-5, 21601-6, 21601-7, 21601-8, 21601-10, 21601-12, 21601-14, 21601-16.
Reason for recall
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
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-1601-2026. 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.