[Recalled] 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 Ream
A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.
Recall details
| 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: 07350137520 |
|---|---|
| Brand / manufacturer | ORTOMA AB |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2615-2025 |
| Country of notice | Sweden |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 28 July 2025 |
| EAN / barcode | 07350137521019 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Due to a weld breakage between the pin and inserter holder of the Inserter Adapter.
This Class II recall concerns device products distributed in Sweden and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.