Device recall
Z-0442-2019: 3.2mm Proximal Reamer/Cannulated Drill provided as part of the Fibulock Fibular…
FDA device recall · Class II · Arthrex, Inc.
Key facts
| Recall number (Z-number) | Z-0442-2019 |
|---|---|
| Recall event | 81119 |
| Product | 3.2mm Proximal Reamer/Cannulated Drill provided as part of the Fibulock Fibular Nail System Pack. FibuLock Nail Procedure Pack: Contains instrumentation for the implantation of the FibuLock implant. Contents include: Actuation Driver, 6.2mm Reamer, 3.2mm Reamer, 2 mm Drill, Spade Tip Guide Wire, and… |
| Product code | HTO |
| Recalling firm | Arthrex, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 1220246 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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