Drug recall
Calix P PEEK Lumbar System, PLIF Rasp
FDA recall event 74397 · Class II · X Spine Systems Inc
Key facts
| Event ID | 74397 |
|---|---|
| Recall numbers | Z-0124-2017, Z-0125-2017, Z-0126-2017, Z-0127-2017 |
| Recalling firm | X Spine Systems Inc |
| Product type | Devices |
| Products | Calix P PEEK Lumbar System, PLIF Rasp, Calix P PEEK Lumbar System, PLIF Trial, Calix T PEEK Lumbar System, TLIF Rasp, Calix T PEEK Lumbar System, TLIF Trial |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The trials and rasps used to prepare the surgical site for placement of the implant may become detached from the inserter assembly part and become lodged in the intervertebral space. |
| Initiation date | May 17, 2016 |
| Report date | Oct 26, 2016 |
| Termination date | Apr 4, 2019 |
| City | Miamisburg |
| State | OH |
| Country | United States |
| FEI number | 3005031160 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: