Drug recall
BIOMET 3i LTX DENTAL IMPLANTS Model LTX610 (6x10mm) - Plastic tray within Tyvek tray within cardboard box; one…
FDA recall event 76809 · Class II · Biomet 3i, LLC
Key facts
| Event ID | 76809 |
|---|---|
| Recall numbers | Z-1701-2017 |
| Recalling firm | Biomet 3i, LLC |
| Product type | Devices |
| Products | BIOMET 3i LTX DENTAL IMPLANTS Model LTX610 (6x10mm) - Plastic tray within Tyvek tray within cardboard box; one (1) unit per box. Labeled Sterile" |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | A single lot of product that potentially has a single part within the lot that does not match the product on the label due to a commingle at the firm supplier |
| Initiation date | Mar 8, 2017 |
| Report date | Apr 5, 2017 |
| Termination date | Aug 2, 2019 |
| City | Palm Beach Gardens |
| State | FL |
| Country | United States |
| FEI number | 1038806 |
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: