FDA Device recall Z-0828-2016
Stryker Aero-AL Impaction handle Catalog Number 48921007
- FDA Device
- Class II
- terminated
- Published 2016-03-02
On 2016-03-02 the FDA classified a Class II recall of Stryker Aero-AL Impaction handle Catalog Number 48921007 by Stryker Spine, citing reported jamming of the impaction handle when assembled to the Inserter guide at the threads.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0828-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-12-18 |
| Published | 2016-03-02 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Stryker Spine |
| Distribution | US |
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.
Reason
Reported jamming of the impaction handle when assembled to the Inserter guide at the threads.
Identifiers
| code_info | Lot #144933, 14D252, and 14D253. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0828-2016%22
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