Device recall
Z-2838-2011: "***3i Incise Custom-Made Label. QP157 Approved 07/09/10*** 3i inc se…
FDA device recall · Class III · Biomet 3i, LLC
Key facts
| Recall number (Z-number) | Z-2838-2011 |
|---|---|
| Recall event | 58769 |
| Product | "***3i Incise Custom-Made Label. QP157 Approved 07/09/10*** 3i inc se Custom-made Dental Framework***Biomet 3i 4555 Riverside Drive Palm Beach Gardens, FL 33410 800-342-5454 www.biomet3i.com Please consult instructions for use and recommendation***For Dental Lab use ONLY Non-sterile/For single… |
| Product code | NSP |
| Recalling firm | Biomet 3i, LLC |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jul 18, 2011 |
| 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