Device recall
Z-2139-2011: ***REF IOSS413*** OSSEIOTITE Certain Implant 4 x 13mm*** Sterile using…
FDA device recall · Class II · Biomet 3i, LLC
Key facts
| Recall number (Z-number) | Z-2139-2011 |
|---|---|
| Recall event | 58326 |
| Product | ***REF IOSS413*** OSSEIOTITE Certain Implant 4 x 13mm*** Sterile using Radiation*** Rx Only***BIOMET 3i Dental Iberica S.L.WTC Almeda Park, Ed, 1, Planta 1 Pl. de la Pau s/n08940 Cornella de Llobregat (Barcelona) Spain*** Biomet 3i Dental Implants are intended for surgical placement in the upper or… |
| Product code | O-FY |
| Recalling firm | Biomet 3i, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 25, 2012 |
| FEI number | 1038806 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database