Device recall
Z-0641-2010: Orthofix Spinal Implants; Pillar SA PEEK Spacer System Instrument Case. Case…
FDA device recall · Class II · Orthofix, Inc
Key facts
| Recall number (Z-number) | Z-0641-2010 |
|---|---|
| Recall event | 53968 |
| Product | Orthofix Spinal Implants; Pillar SA PEEK Spacer System Instrument Case. Case contents: Implant Insertion Instrument, Straight Tamp, Bone Awl Drill Guide, Straight Drill, U-Joint Driver with and without retention, Flex Shaft Driver, Trial Insertion Instrument, Drill Tips, Cover Plate Inserter, Cover… |
| Product code | MQP |
| Recalling firm | Orthofix, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 2, 2010 |
| 510(k) numbers | K081849 |
| FEI number | 2183449 |
At a glance
- 1–9 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