FDAJune 14, 2016device
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...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
stryker instruments divstrykerstryker instruments
Recall history
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- FDABW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER2026-04-10
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