Device recall
Z-1286-2012: Product is labeled in part: "***REF: 01-7036, LOT 999999, "1.5MM" SYSTEM PLATE…
FDA device recall · Class II · Biomet Microfixation, LLC
Key facts
| Recall number (Z-number) | Z-1286-2012 |
|---|---|
| Recall event | 61207 |
| Product | Product is labeled in part: "***REF: 01-7036, LOT 999999, "1.5MM" SYSTEM PLATE L-SHAPE, 3 X 3 HOLE, 100 DEGREE, QTY 00001, CE 0086, 2010-04 *** NON-STERILE PRODUCT ***, LEFT, X-LONG, 0.6 MM TITANIUM, BIOMET MICROFIXATION, 1540 TRADEPORT DRIVE, JACKSONVILLE, FL 32218 USA, 01-736, LOT 999999, QTY… |
| Product code | JEY |
| Recalling firm | Biomet Microfixation, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 18, 2012 |
| 510(k) numbers | K953385 |
| 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