Recall Z-2615-2025— ORTOMA AB

Name: FDA recall Z-2615-2025
Creator: U.S. Food and Drug Administration
Published: 2025-07-28

Class II · Ongoing

Class II FDA medical device recall by ORTOMA AB, initiated 2025-07-28. It names 2 FDA 510(k) clearances: K250086, K232140. 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: Due to a weld breakage between the pin and inserter holder of the Inserter Adapter..

Recalling firm: ORTOMA AB
Classification: Class II
Status: Ongoing
Initiated: 2025-07-28
Firm location: Goteborg, N/A, Sweden

510(k) clearances named in this recall

2 on FDA's record

K250086 — OTS HipOrtoma AB·cleared 2025-05-16
K232140 — OTS HipOrtoma AB·cleared 2024-03-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.