Alphatec Recalls Arsenal Spinal Fixation System Set Screws
Alphatec Spine is recalling Arsenal Spinal Fixation System Set Screws due to a trend of postoperative disengagement from the screw body.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect (disengagement) in a spinal fixation device, which poses a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Alphatec Spine, Inc. is recalling the Arsenal Spinal Fixation System Set Screw, Part No. 47027. The recall involves 16,959 units of the device, which is intended for posterior, non-cervical, spinal fixation as an adjunct to fusion for the treatment of degenerative disease, deformity, and trauma indications.
The recall is being conducted due to a trend in set screw postoperative disengagement from the screw body. The affected devices were distributed worldwide, including nationwide in the United States in the states of Texas, Alabama, Utah, Florida, Iowa, South Dakota, Nevada, Ohio, California, Minnesota, Colorado, Arizona, Oklahoma, Michigan, Virginia, Kentucky, and Puerto Rico, as well as in Japan.
Healthcare providers and patients should contact Alphatec Spine, Inc. for further information regarding the recall and potential replacement or repair options. The source text does not report any specific injuries or illnesses associated with this defect.
The recalled product
- Product
- 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 treatment of degenerative disease, deformity, and trauma indications. The…
- Manufacturer
- Alphatec Spine, Inc.
- Category
- Medical Device — Spinal Fixation
- Hazard
- Affected units
- 16,959
Distribution
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