Ortoma Inserter Adapter OTD: Inserter Adapter OTD recall
Ortoma Inserter Adapter OTD: Inserter Adapter OTD Straight REF 30-201 Model Number: 2001 UDI-DI code: 07350137521019 Inserter Adapter OTD Pinnacle…
Why was Ortoma Inserter Adapter OTD: Inserter Adapter OTD recalled?
Due to a weld breakage between the pin and inserter holder of the Inserter Adapter.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- Ortoma Inserter Adapter OTD: Inserter Adapter OTD Straight REF 30-201 Model Number: 2001 UDI-DI code: 07350137521019 Inserter Adapter OTD Pinnacle…
- Recalling firm
- ORTOMA AB
- Quantity
- 261 devices
- Distribution
- Worldwide - U.S. Nationwide distribution in the state of FL and the countries of Japan, Sweden.
- Recall date
- October 1, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)