Ortoma Inserter Adapter OTD: Inserter Adapter OTD Straight REF 30-201… — Class II medical device recall Z-2615-2025
Ongoing recall by ORTOMA AB, reported 2025-10-01, distributed nationwide. Due to a weld breakage between the pin and inserter holder of the Inserter Adapter.
| Recall number | Z-2615-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ORTOMA AB, Goteborg, N/A, Sweden |
| Recall initiated | 2025-07-28 |
| Classified | 2025-09-22 |
| Reported by FDA | 2025-10-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | JP, SE |
| Quantity | 261 devices |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 07350137520081, 07350137520098, 07350137520593, 07350137521019 |
| Lot numbers | 20242001, 20242008, 20244803, 20245103, 20245104, 20245109, 20245119 |
| Model numbers | 1001, 1003, 1004, 2001, 30-157, 30-158, 30-201, 30-202 |
Product
Ortoma Inserter Adapter OTD: Inserter Adapter OTD Straight REF 30-201 Model Number: 2001 UDI-DI code: 07350137521019 Inserter Adapter OTD Pinnacle Straight REF 30-202 Model Number: 1001 UDI-DI code: 07350137520593 Reamer Adapter OTD REF 30-157 Model Number: 1003 UDI-DI code: 07350137520081 Inserter Adapter OTD REF 30-158 Model Number: 1004 UDI-DI code: 07350137520098 The Inserter Adapters are intended to be attached to a Cup Inserter Tool. The Cup Inserter Tool (impactor) is intended to be tracked by and navigated to orient and position the hip implant cup correctly relative to preoperative planned position and orientation.
Reason for recall
Due to a weld breakage between the pin and inserter holder of the Inserter Adapter.
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-2615-2025. 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.