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ORTOMA AB recalls Ortoma Inserter Adapter OTD: Inserter Adapter OTD Straight REF 30-201 Model Number: 2001 UDI-DI code: 07350137521019
Recalled October 1, 2025 · FDA recall Z-2615-2025 · ORTOMA AB
Hazard
Due to a weld breakage between the pin and inserter holder of the Inserter Adapter. · FDA Class II
Units
261 devices
Sold at
Worldwide - U.S. Nationwide distribution in the state of FL and the countries of Japan, Sweden.
Description
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 relative to preoperative planned position and orientation.
Manufacturer(s)
ORTOMA AB
Made in
Sweden
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →