ORTOMA AB: Device Recall

Recall #Z-2615-2025 · 07/28/2025

Class II: Risk

Recall Details

Recall Number: Z-2615-2025
Classification: Class II
Product Type: Device
Recalling Firm: ORTOMA AB
Status: Ongoing
Date Initiated: 07/28/2025
Location: Goteborg, N/A, Sweden
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 261 devices

Reason for Recall

Due to a weld breakage between the pin and inserter holder of the Inserter Adapter.

Product Description

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.

Distribution Pattern

Worldwide - U.S. Nationwide distribution in the state of FL and the countries of Japan, Sweden.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.