[Recalled] Arsenal Spinal Fixation System, Set Screw, Part No. 47127 Product Usage: Usage: The Arsenal Spinal Fixation System is intended for posterior, non-cervical, spinal fixation as an adjunct to fusion for the treatment of degenerat
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| Product | Arsenal Spinal Fixation System, Set Screw, Part No. 47127 Product Usage: Usage: The Arsenal Spinal Fixation System is intended for posterior, non-cervical, spinal fixation as an adjunct to fusion for the treatment of degenerative disease, deformity, and trauma indications. The Arsenal System cons |
|---|---|
| Brand / manufacturer | Alphatec Spine, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0592-2017 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 05 October 2016 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Alphatec Spine is recalling the Arsenal Spinal Fixation System Set Screw due to a trend in set screw postoperative disengagement from the screw body.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Alphatec Spine, Inc.
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.