Device recall
Z-2158-2012: ***REF IFNT611***Full OSSEOTITE Tapered Certain Implant 6 x 11.5mm***Sterile by…
FDA device recall · Class II · Biomet 3i, LLC
Key facts
| Recall number (Z-number) | Z-2158-2012 |
|---|---|
| Recall event | 62375 |
| Product | ***REF IFNT611***Full OSSEOTITE Tapered Certain Implant 6 x 11.5mm***Sterile by 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. Lot #2011110798. Intended for surgical placement in the upper or lower… |
| Product code | NHA |
| Recalling firm | Biomet 3i, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 16, 2013 |
| 510(k) numbers | K063341 |
| FEI number | 1038806 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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