Drug recall
ImplantDirect Legacy 4 Implant, 5.7mmD x 5.7mmD Platform, Part 885708, Rx, Sterile. The incorrect cap label…
FDA recall event 79885 · Class II · Implant Direct Sybron Manufacturing, LLC
Key facts
| Event ID | 79885 |
|---|---|
| Recall numbers | Z-1920-2018 |
| Recalling firm | Implant Direct Sybron Manufacturing, LLC |
| Product type | Devices |
| Products | ImplantDirect Legacy 4 Implant, 5.7mmD x 5.7mmD Platform, Part 885708, Rx, Sterile. The incorrect cap label shows part 855708, 5.7mmD Platform, 8mmL. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The vial cap was mislabeled with the incorrect part number of 855708 but the product description on the cap was correct. The main vial label was correctly labeled. |
| Initiation date | Nov 15, 2016 |
| Report date | May 30, 2018 |
| Termination date | Jun 4, 2018 |
| City | Westlake Village |
| State | CA |
| Country | United States |
| FEI number | 3001617766 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: