Home / Recalls / Stryker Instruments Div. Of Stryker Corporation / Z-2536-2016

Z-2536-2016 Class II Terminated

Recalled by Stryker Instruments Div. Of Stryker Corporation — Portage, MI

FDA device recall Z-2536-2016 was initiated by Stryker Instruments Div. Of Stryker Corporation on Jun 14, 2016 and is designated Class II. 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… The recall status is terminated (terminated Mar 27, 2017). Affected quantity: 4,841 boxes (9,682 units).

Recall details

Product Type: Devices
Report Date: Aug 24, 2016
Initiation Date: Jun 14, 2016
Termination Date: Mar 27, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 4,841 boxes (9,682 units)

Product description

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.

Distribution pattern

Worldwide distribution. US nationwide, France, Netherlands, Spain, Italy, Canada, Israel, Romania, Switzerland, and United Kingdom.

Code information

Model Number(s): 0607-687-000 0605-887-000 0605-687-000 0605-683-000 0607-687-000 Lot numbers: 16021012, 16027022, 16049012, 16061012, 16092012, 16107012, 16022012, 16028012, 16049022, 16063012, 16098012, 16109012, 16025012, 16028022, 16049032, 16063022, 16100012, 16109022, 16025022, 16033012, 16053012, 16070012, 16104012, 16113022, 16026012, 16041012, 16056012, 16070022, 16104022, 16113032, 16026022, 16048012, 16056022, 16074012, 16105012, 16118012, 16027012, 16048022, 16060012, 16088012, 16106012, 16118022 0605-887-000 Lot numbers: 16041012, 16040012, 16050012, 16057012, 16069012, 16078012, 16104012, 16112012, 16124012 0605-687-000 Lot numbers: 16041012, 16047012, 16111012 0605-683-000 Lot numbers: 16071012

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-2536-2016
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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