# FDA recall Z-2615-2025

> **ORTOMA AB** · Class II · device recall initiated 2025-07-28.

## 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 for recall

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

## Distribution

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

## Key facts

- **Recall number:** Z-2615-2025
- **Recalling firm:** ORTOMA AB
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-07-28
- **Report date:** 2025-10-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Goteborg, N/A, Sweden

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2615-2025

## Citation

> AI Analytics. FDA recall Z-2615-2025. Retrieved 2026-09-03 from https://api.ai-analytics.org/recall/Z-2615-2025. Source: US FDA. Licensed CC0.

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