ORTOMA AB recalls Ortoma Inserter Adapter OTD: Inserter Adapter OTD Straight REF 30-201 Model Number: 2001 UDI-DI code: 07350137521019 In…

Recall date

July 28, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2615-2025

FDA classification

Class II

Brand / firm

ORTOMA AB

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.