[Recalled] ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform, — Packaged dental implant contains a different size then the size declared on the… | FDA 2021-09-23
Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.
Recall details
| Product | ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform, |
|---|---|
| Brand / manufacturer | Implant Direct Sybron Manufacturing LLC |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0198-2022 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 23 September 2021 |
| EAN / barcode | 10841307101796 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Packaged dental implant contains a different size then the size declared on the labeling.
This Class II recall concerns device products distributed in United States 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 Implant Direct Sybron Manufacturing LLC
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.