ORTOMA AB: Medical Device Recall in 2025 - (Recall #: Z-2615-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: July 28, 2025

Date Posted: October 1, 2025

Recall Number: Z-2615-2025

Event ID: 97416

Reason for Recall:

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

Status: Ongoing

Product Quantity: 261 devices

Code Information:

Model Number: 2001 Catalog Number: 30-201 UDI-DI code: 07350137521019 Lot Numbers: 20244803 Model Number: 1001 Catalog Number: 30-202 UDI-DI code: 07350137520593 Lot Numbers: 20245103 20245104 20245109 Model Number: 1003 Catalog Number: 30-157 UDI-DI code: 07350137520081 Lot Numbers: 20242001 20242008 20245119 Model Number: 1004 Catalog Number: 30-158 UDI-DI code: 07350137520098 Only distributed O.U.S.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated