Device recall
Z-0108-2011: 2.0/1.0 4 hole long plate (titanium plate).Lot 120150. Product labeling reads…
FDA device recall · Class II · Biomet Microfixation, Inc.
Key facts
| Recall number (Z-number) | Z-0108-2011 |
|---|---|
| Recall event | 56802 |
| Product | 2.0/1.0 4 hole long plate (titanium plate ).Lot 120150. Product labeling reads: (1. ) REF: 01-9205, Lot 999999, " 2.0MM" SYSTEM PLATE 4 HOLE PLATE, STRAIGHT, LONG. (2.) QTY 00001, CE 0086, *** NON-STERILE PRODUCT***, 1.0 MM TITANIUM, BIOMET MICROFIXATION, 1520 TRADEPORT DRIVE, JACKSONVILLE, FL 32218… |
| Product code | JEY |
| Recalling firm | Biomet Microfixation, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 19, 2010 |
| 510(k) numbers | K854886 |
| FEI number | 1032347 |
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