Stryker Aero-AL Impaction handle Catalog Number 48921007 — Class II medical device recall Z-0828-2016
Terminated recall by Stryker Spine, reported 2016-03-02, distributed nationwide. Reported jamming of the impaction handle when assembled to the Inserter guide at the threads.
| Recall number | Z-0828-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Spine, Allendale, NJ, United States |
| Recall initiated | 2015-12-18 |
| Classified | 2016-02-19 |
| Reported by FDA | 2016-03-02 |
| Terminated | 2016-08-01 |
| Distributed | Nationwide (US) |
| Quantity | 31 units |
| Lot numbers | 144933, 14D252, 14D253 |
| Model numbers | 48921007 |
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 for recall
Reported jamming of the impaction handle when assembled to the Inserter guide at the threads.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0828-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.