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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 64072

4 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
January 15, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
DePuy Spine, Inc.

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.

How coverage and grouping work

Complete imported group

Every recalled product in this event

4 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 4

DePuy CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT Catalog Number:283905000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.

Z-0960-2013
Recall number
Z-0960-2013
Initiated
January 15, 2013
Classification
Class II
Status
Terminated
Recalling firm
DePuy Spine, Inc.
Quantity
1023

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck

Code information

All lots

Distribution pattern

Worldwide Distribution-USA (nationwide) and the countries of Argentina, Armenia, Kazakhstan, Russia, Ukraine, Australia, Austria Belgium, Luxembourg , Brazil, Canada, China, Colombia, Cyprus, Jordan Lebanon, Saudi Arabia, UAE, Czech Republic, Finland ,France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Latvia, Malaysia Mexico, Netherlands, New Zealand, Norway, Sweden, Poland, Portugal Singapore, Slovakia, Slovenia, South Africa, Spain, Switzerland, Turkey, and UK.

device · product 2 of 4

DePuy CONFIDENCE SPINAL CEMENT SYSTEM 7CC KIT Catalog Number: 283907000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.

Z-0961-2013
Recall number
Z-0961-2013
Initiated
January 15, 2013
Classification
Class II
Status
Terminated
Recalling firm
DePuy Spine, Inc.
Quantity
549

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck

Code information

All lots

Distribution pattern

Worldwide Distribution-USA (nationwide) and the countries of Argentina, Armenia, Kazakhstan, Russia, Ukraine, Australia, Austria Belgium, Luxembourg , Brazil, Canada, China, Colombia, Cyprus, Jordan Lebanon, Saudi Arabia, UAE, Czech Republic, Finland ,France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Latvia, Malaysia Mexico, Netherlands, New Zealand, Norway, Sweden, Poland, Portugal Singapore, Slovakia, Slovenia, South Africa, Spain, Switzerland, Turkey, and UK.

device · product 3 of 4

DePuy CONFIDENCE SPINAL CEMENT SYSTEM 11C Plus KIT Catalog Number: 283910000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.

Z-0962-2013
Recall number
Z-0962-2013
Initiated
January 15, 2013
Classification
Class II
Status
Terminated
Recalling firm
DePuy Spine, Inc.
Quantity
7773

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck

Code information

All lots

Distribution pattern

Worldwide Distribution-USA (nationwide) and the countries of Argentina, Armenia, Kazakhstan, Russia, Ukraine, Australia, Austria Belgium, Luxembourg , Brazil, Canada, China, Colombia, Cyprus, Jordan Lebanon, Saudi Arabia, UAE, Czech Republic, Finland ,France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Latvia, Malaysia Mexico, Netherlands, New Zealand, Norway, Sweden, Poland, Portugal Singapore, Slovakia, Slovenia, South Africa, Spain, Switzerland, Turkey, and UK.

device · product 4 of 4

DePuy CONFIDENCE SPINAL CEMENT SYSTEM KIT Catalog Number: 283913000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.

Z-0963-2013
Recall number
Z-0963-2013
Initiated
January 15, 2013
Classification
Class II
Status
Terminated
Recalling firm
DePuy Spine, Inc.
Quantity
6668

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck

Code information

All lots

Distribution pattern

Worldwide Distribution-USA (nationwide) and the countries of Argentina, Armenia, Kazakhstan, Russia, Ukraine, Australia, Austria Belgium, Luxembourg , Brazil, Canada, China, Colombia, Cyprus, Jordan Lebanon, Saudi Arabia, UAE, Czech Republic, Finland ,France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Latvia, Malaysia Mexico, Netherlands, New Zealand, Norway, Sweden, Poland, Portugal Singapore, Slovakia, Slovenia, South Africa, Spain, Switzerland, Turkey, and UK.