Device recall
Z-0412-2018: SST TWIST DRILL, STANDARD, 1.6mm Dia. x 127mm, REF 8054-010, STERILE This…
FDA device recall · Class II · MicroAire Surgical Instruments, LLC
Key facts
| Recall number (Z-number) | Z-0412-2018 |
|---|---|
| Recall event | 78687 |
| Product | SST TWIST DRILL, STANDARD, 1.6mm Dia. x 127mm, REF 8054-010, STERILE This product line is intended for use in orthopaedic surgery (large and small bone surgeries) to cut bone |
| Product code | HTW |
| Recalling firm | MicroAire Surgical Instruments, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 29, 2018 |
| FEI number | 2020601 |
At a glance
- None 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