Recall Z-2615-2025 ยท OLO Orthopedic Stereotaxic Instrument
ORTOMA AB
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
| Date | Sep 22, 2025 (initiated Jul 28, 2025) |
| Status | Open, Classified |
| Reason | Due to a weld breakage between the pin and inserter holder of the Inserter Adapter. |
| Root cause | Process control |
| Action | On 07/28/2025, the firm sent via email an "URGENT: MEDICAL DEVICE FIELD CORRECTION" Letter to customers informing them that the Insert Adapter OTD Straight pin may partially or completely break. This malfunction, if not identified, may result in displaying incorrect information of the reaming or cup placement by OTS Hip Guide. The values displayed on the screen may not correctly represent the actual angle and position of the tool. The magnitude of the resulting error can vary and depends on the level of the weld breakage. Customers are instructed to: 1. Discontinue use and quarantine affected |
| Quantity | 261 devices |
| Distribution | Worldwide - U.S. Nationwide distribution in the state of FL and the countries of Japan, Sweden. |
| FDA record | Open on fda.gov |