Device recall
Z-2799-2011: "***REF IWTH56***Certain EP HEALING ABUTMENT 5mm(D) X 5mm(P) X 6mm(H).***…
FDA device recall · Class III · Biomet 3i, LLC
Key facts
| Recall number (Z-number) | Z-2799-2011 |
|---|---|
| Recall event | 58768 |
| Product | "***REF IWTH56***Certain EP HEALING ABUTMENT 5mm(D) X 5mm(P) X 6mm(H).*** Healing abutment*** STERILE.***Rx Only.*** Made in USA*** Implant Innovations, Inc. Global Headquarters 4555 Riverside Drive, Palm Beach Gardens, FL 33410 USA Tel: (800) 342-5454 www.3i.online.com. Outside US… |
| Product code | NSQ |
| Recalling firm | Biomet 3i, LLC |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Nov 9, 2011 |
| 510(k) numbers | K934126 |
| 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