Alphatec Recalls Arsenal Spinal Fixation System Set Screws for Disengagement Risk
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 risk-of-harm product (spinal implant) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Alphatec Spine, Inc. is recalling the Arsenal Spinal Fixation System Set Screw, Part No. 47127. The recall involves 16,972 units distributed worldwide, including the United States, Japan, the UK, NSW, and Spain.
The recall is being conducted due to a trend in set screw postoperative disengagement from the screw body. 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 specific components involved are manufactured from surgical grade titanium alloy.
This recall is classified as Class II by the U.S. Food and Drug Administration. Patients who have had these specific set screws implanted should contact their healthcare provider to discuss the recall and any necessary follow-up care.
The recalled product
- 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.…
- Manufacturer
- Alphatec Spine, Inc.
- Affected units
- 16,972
Distribution
Distributed nationwide across the United States.
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