Device recall
Z-1151-2010: BIOMET MICROFIXATION, "1.5MM" SYSTEM BONE SCREW LP, SELF DRILL, X-DRIVE…
FDA device recall · Class III · Biomet Microfixation, Inc.
Key facts
| Recall number (Z-number) | Z-1151-2010 |
|---|---|
| Recall event | 54372 |
| Product | BIOMET MICROFIXATION, "1.5MM" SYSTEM BONE SCREW LP, SELF DRILL, X-DRIVE, SGL.LEAD AUGER POINT, 1.5 X 3.5MM, TITANIUM, NON STERILE PRODUCT. Model 01-7293 and 99-7293-01. BIOMET MICROFIXATION, 1520 TRADEPORT DRIVE, JACKSONVILLE, FL 32218 USA. Used along with implantable bone plates for oral… |
| Product code | JEY |
| Recalling firm | Biomet Microfixation, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Apr 7, 2010 |
| 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