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.
FDA Recall Z-2536-2016 · Posted 2016-08-15
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Recalling FirmStryker Instruments Div. of Stryker Corporation
Recall StatusTerminated
Product CodeNDN
Date Initiated2016-06-14
Date Terminated2017-03-27
Product Quantity4,841 boxes (9,682 units)
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.
Firm Action
On 6/13/2016, URGENT MEDICAL DEVICE RECALL NOTIFICATION notifications were sent to the affected customers via courier and sales representatives via email. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions regarding this recall, please contact Stryker Instruments:
Jennifer Olson
269-389-2644
[email protected]
Root Cause
Process control
Distribution Pattern
Worldwide distribution. US nationwide, France, Netherlands, Spain, Italy, Canada, Israel, Romania, Switzerland, and United Kingdom.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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