Device recall
Z-0810-2010: LOCATOR Restorative Abutment, ILOA002, LOT 877423, Certain LOCATOR ABUTMENT, 4.1…
FDA device recall · Class II · Biomet 3i, LLC
Key facts
| Recall number (Z-number) | Z-0810-2010 |
|---|---|
| Recall event | 54074 |
| Product | LOCATOR Restorative Abutment, ILOA002, LOT 877423, Certain LOCATOR ABUTMENT, 4.1 mm(D) X 2mm(H), STERILE Made in USA, Sterile. BIOMET 3i 4555 Riverside Drive, Palm Beach Gardens, FL 33410 USA. For use on tissue supported removable over-dentures on 2 to 4 implants, partially edentulous overdentures… |
| Product code | DZE |
| Recalling firm | Biomet 3i, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 15, 2010 |
| 510(k) numbers | K012911 |
| 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