Z-2536-2016Class II

Stryker AutoPlex System. Model Numbers 0607-687-000, 0605-887-000, 0605-687-000, and 0605-683-000. For bone...

Name: Z-2536-2016 Stryker AutoPlex System. Model Numbers 0607-687-000, 0605-887-000, 0605-687-000, and 0605-683-000. For bone...
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2016-06-14
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2016-06-14 / Terminated / root cause: manufacturing process

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of 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... on 2016-06-14. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2536-2016
Classification: Class II
Status: Terminated
Initiated: 2016-06-14
Posted: 2016-08-15
Terminated: 2017-03-27
Recalling firm: Stryker Corp.
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.
Product code: NDN Cement, Bone, Vertebroplasty
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.
Root cause tag: manufacturing process
FDA root cause: Process control
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]
Quantity in commerce: 4,841 boxes (9,682 units)
Distribution: Worldwide distribution. US nationwide, France, Netherlands, Spain, Italy, Canada, Israel, Romania, Switzerland, and United Kingdom.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2536-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2536-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-24	2016-08-15

Product code NDN

K150582Class IIVertaplex® High Viscosity (HV) Radiopaque Bone CementStryker Corporation / cleared 2015-06-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)