Stryker Aero-AL Impaction Handle Recalled for Jamming Defect
Stryker Spine is recalling 31 Aero-AL Impaction Handles due to reported jamming when assembled to the Inserter guide.
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 source text describes a mechanical jamming issue without reporting any injuries, hospitalizations, or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
Stryker Spine is recalling 31 units of the Aero-AL Impaction Handle, Catalog Number 48921007. The product is manufactured by Stryker Spine SAS France and is used to facilitate the insertion of the Aero-AL cage into the disc space.
The recall was initiated due to reported jamming of the impaction handle when it is assembled to the Inserter guide at the threads. The affected units are identified by Lot numbers 144933, 14D252, and 14D253.
The product was distributed nationwide. Healthcare facilities and users should stop using the affected handles and contact Stryker Spine for instructions on return or replacement.
The recalled product
- Product
- Stryker Aero-AL Impaction handle Catalog Number 48921007. Stryker Spine Manufactured by : Stryker Spine SAS France Used to facilitate insertion of the Aero-AL cage into the disc space.
- Manufacturer
- Stryker Spine
- Hazard
- Affected units
- 31
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 (3)
- Lot #144933
- 14D252
- and 14D253.
Distribution
Distributed nationwide across the United States.
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