Class II — ORTOMA AB
| Recalling firm | Ortoma AB |
|---|---|
| Registered facility | ORTOMA AB (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Due to a weld breakage between the pin and inserter holder of the Inserter Adapter. |
| 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 relati… |
| Quantity | 261 devices |
| Distribution | Worldwide - U.S. Nationwide distribution in the state of FL and the countries of Japan, Sweden. |
| Initiated | 2025-07-28 |
| Classified | 2025-09-22 |
| Recall number | Z-2615-2025 |
| 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 — ORTOMA AB (Z-2615-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97416/
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