Drug recall
Arsenal Spinal Fixation System, Set Screw, Part No. 47027 Product Usage: The Arsenal Spinal Fixation System is…
FDA recall event 77220 · Class II · Alphatec Spine, Inc.
Key facts
| Event ID | 77220 |
|---|---|
| Recall numbers | Z-2249-2017 |
| Recalling firm | Alphatec Spine, Inc. |
| Product type | Devices |
| Products | Arsenal Spinal Fixation System, Set Screw, Part No. 47027 Product Usage: The Arsenal Spinal Fixation System is intended for posterior, non-cervical, spinal fixation as an adjunct to fusion for the… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Alphatec Spine is recalling the Arsenal Spinal Fixation System Set Screw due to a trend in set screw postoperative disengagement from the screw body. |
| Initiation date | May 5, 2017 |
| Report date | Jun 14, 2017 |
| Termination date | Jun 6, 2017 |
| City | Carlsbad |
| State | CA |
| Country | United States |
| FEI number | 2027467 |
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: