Stryker AutoPlex System — Class II medical device recall Z-2536-2016
Terminated recall by Stryker Instruments Div. of Stryker Corporation, reported 2016-08-24, distributed nationwide. The Piston Head can become separated from the Delivery Piston, blocking the injection assembly Valve resulting
| Recall number | Z-2536-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Instruments Div. of Stryker Corporation, Portage, MI, United States |
| Recall initiated | 2016-06-14 |
| Classified | 2016-08-15 |
| Reported by FDA | 2016-08-24 |
| Terminated | 2017-03-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CH, ES, FR, GB, IL, IT, NL, RO |
| Lot numbers | 0605-683-000, 0605-687-000, 0605-887-000, 16021012, 16022012, 16025012, 16025022, 16026012, 16026022, 16027012, 16027022, 16028012, 16028022, 16033012, 16040012, 16041012, 16047012, 16048012, 16048022, 16049012, 16049022, 16049032, 16050012, 16053012, 16056012, 16056022, 16057012, 16060012, 16061012, 16063012, 16063022, 16069012, 16070012, 16070022, 16071012, 16074012, 16078012, 16088012, 16092012, 16098012 and 15 more |
| Model numbers | 0605-683-000, 0605-687-000, 0605-887-000, 0607-687-000, 16021012, 16022012, 16025012, 16025022, 16026012, 16026022, 16027012, 16027022, 16028012, 16028022, 16033012, 16040012, 16041012, 16047012, 16048012, 16048022, 16049012, 16049022, 16049032, 16050012, 16053012 and 31 more |
Product
Stryker AutoPlex System. Model Numbers 0607-687-000, 0605-887-000, 0605-687-000, and 0605-683-000. For bone cement. Stryker AutoPlex System kits contain a cement mixer, cement injector, funnel, and an extension tube assembly whereby bone cement powder and liquid monomer are mixed inside a chamber and transferred into a cement injector automatically. The bone cement is then dispensed directly into a fracture site using the cement injector and introducer needle combination.
Reason for recall
The Piston Head can become separated from the Delivery Piston, blocking the injection assembly Valve resulting in a cement backflow towards the injector handle. Potential for delay in surgery if additional cement needs to be prepared for the injection procedure.
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-2536-2016. 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.