[Recalled] ORTHOFIX Catalogue Number: ref 1-1355001, DRILL BIT D.2,7 MM L.127 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18054242S10918 — As a result of complaint investigations it was determined that batches of drill… | F
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| Product | ORTHOFIX Catalogue Number: ref 1-1355001, DRILL BIT D.2,7 MM L.127 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18054242S10918 |
|---|---|
| Brand / manufacturer | Orthofix Srl |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0385-2020 |
| Country of notice | Italy |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 27 September 2018 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance.
This Class II recall concerns device products distributed in Italy 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 →
Related recalls from Orthofix Srl
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.