Ortoma Inserter Adapter OTD: Inserter Adapter OTD Straight REF 30-201 Model Number: 2001 UDI-DI code: 07350137521019 Inserter Adapter OTD P…
ORTOMA AB · Due to a weld breakage between the pin and inserter holder of the Inserter Adapter.
- Status
- Ongoing
- City
- Goteborg
- State
- N/A
- Country
- Sweden
- Classification
- Class II
- Product type
- Devices
- Event ID
- 97416
- Recalling firm
- ORTOMA AB
- Address 1
- Falkenbergsgatan 3
- Address 2
- N/A
- Postal code
- N/A
- Voluntary mandated
- Voluntary: Firm initiated
- Initial firm notification
- Letter
- Distribution pattern
- Worldwide - U.S. Nationwide distribution in the state of FL and the countries of Japan, Sweden.
- Recall number
- Z-2615-2025
- Product quantity
- 261 devices
- Reason for recall
- Due to a weld breakage between the pin and inserter holder of the Inserter Adapter.
- Recall initiation date
- 20250728
- Center classification date
- 20250922
- Report date
- 20251001
- 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.
- Code info
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.