Stryker Instruments Div. of Stryker Corporation: Medical Device Recall in 2016 - (Recall #: Z-2536-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: June 14, 2016

Date Posted: August 24, 2016

Recall Number: Z-2536-2016

Event ID: 74582

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.

Status: Terminated

Product Quantity: 4,841 boxes (9,682 units)

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated