Device recall
Z-2227-2009: 3i Custom # 5753, OSCM2913, 2.9MMX 3.4MM X 13MM, OSSEOTITE CUSTOM, MICROMINI…
FDA device recall · Class II · Biomet 3i, LLC
Key facts
| Recall number (Z-number) | Z-2227-2009 |
|---|---|
| Recall event | 52631 |
| Product | 3i Custom # 5753, OSCM2913, 2.9MMX 3.4MM X 13MM, OSSEOTITE CUSTOM, MICROMINI IMPLANT, LOT # 470258, Sterile. Implant Innovations, Inc. 4555 Riverside Drive, Palm Beach Gardens, FL 33410. Custom temporary cover screws are for use in maintaining the soft tissue during the healing process of a dental… |
| Product code | NDA |
| Recalling firm | Biomet 3i, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 1, 2009 |
| 510(k) numbers | K072642 |
| FEI number | 1038806 |
At a glance
- 1–9 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