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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74582

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
June 14, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Stryker Instruments Div. of Stryker Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

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Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-2536-2016
Recall number
Z-2536-2016
Initiated
June 14, 2016
Classification
Class II
Status
Terminated
Quantity
4,841 boxes (9,682 units)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

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Inspect official wording and provenance

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.

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.