Stryker Spine AVS Aria Cage Recalled for Incorrect Marker Placement
Stryker Spine is recalling five AVS Aria Cage units because the anterior and posterior markers were placed on the incorrect sides of the device.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the defect involves incorrect marker placement which is a labeling/identification issue rather than a direct structural failure or reported injury.
Plain-English summary
Stryker Spine is recalling five units of the AVS Aria Cage, Catalog Number 48753212, Lot Number 7HX. The recall was initiated because the anterior and posterior markers on the cage were located on the incorrect or opposite sides of the device.
These intervertebral body fusion devices are indicated for use with autogenous bone graft in patients with degenerative disc disease at one level or two contiguous levels from L2 to S1. The affected units were distributed nationwide in California, Florida, Georgia, Michigan, Minnesota, New Jersey, New Mexico, and Oregon.
Healthcare providers should stop using the affected devices and contact Stryker Spine for further instructions. Patients who have had these devices implanted should contact their healthcare provider to discuss the recall.
The recalled product
- Product
- AVS Aria Cage, Catalog Number 48753212 Product Usage: The Stryker Spine AVS¿ ARIA 1M PEEK Spacers are intervertebral body fusion devices indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from…
- Manufacturer
- Stryker Spine
- Category
- Medical Device — Spinal Implant
- Hazard
- Affected units
- 5
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number 7HX
Distribution
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