Device recall
Z-0538-2010: Biomet 1.1 X 50MM, 3.5MM STOP STAINLESS STEEL, 1.5MM SYSTEM TWIST DRILL WITH J…
FDA device recall · Class II · Biomet Microfixation, Inc.
Key facts
| Recall number (Z-number) | Z-0538-2010 |
|---|---|
| Recall event | 53943 |
| Product | Biomet 1.1 X 50MM, 3.5MM STOP STAINLESS STEEL, 1.5MM SYSTEM TWIST DRILL WITH J NOTCH, REF 01-7141. DISTRIBUTED BY: BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA. A single use twist drill intended for drilling holes in large and small bone during orthopedic, spinal… |
| Product code | HBE |
| Recalling firm | Biomet Microfixation, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 2, 2010 |
| 510(k) numbers | K062842 |
| 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