CLASS II Device recall · Reported 27 Mar 2013 · FDA Enforcement Report

DePuy Confidence Spinal Cement System 7CC Kit recalled by DePuy Spine

DePuy Spine is recalling DePuy Confidence Spinal Cement System 7CC Kit, distributed nationwide in the US. The recall was initiated on 15 Jan 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lots

Quantity recalled549

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0961-2013
FDA event ID: 64072
Recalling firm: DePuy Spine, Raynham, MA
Classification: Class II
Status: Terminated
Recall initiated: 15 Jan 2013
FDA classified: 18 Mar 2013
Reported: 27 Mar 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Spinal Implants

Timeline

15 Jan 2013	Recall initiated by company
18 Mar 2013	Classified by FDA	+62 days
27 Mar 2013	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

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.

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

All lots

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 64072

This product is part of a recall event; the main page for the event is DePuy Confidence Spinal Cement System 11C Plus Kit recalled.

Reported	Class	Recall	Company	Reason	Where
27 Mar 2013	CLASS II	DePuy Confidence Spinal Cement System 11C Plus Kit recalled	DePuy Spine	Device Malfunction	Nationwide
27 Mar 2013	CLASS II	DePuy Confidence Spinal Cement System Kit recalled by DePuy Spine	DePuy Spine	Device Malfunction	Nationwide
27 Mar 2013	CLASS II	DePuy Confidence Spinal Cement System 5CC Kit recalled by DePuy Spine	DePuy Spine	Device Malfunction	Nationwide

More recalls from DePuy Spine

All 36

Reported	Class	Recall	Company	Reason	Where
13 Jul 2022Device	CLASS II	EIT CIF cage, H, 8degree, L- an intervertebral body fusion recalled	DePuy Spine	Packaging Defects	Nationwide
13 Jul 2022Device	CLASS II	EIT CIF cage, H, 8degree, S- an intervertebral body fusion recalled	DePuy Spine	Packaging Defects	Nationwide
8 May 2019Device	CLASS II	Concorde Lift, Lordotic Expandable Interbody Device recalled	DePuy Spine	Other	Nationwide
8 May 2019Device	CLASS II	Concorde Lift, Expandable Interbody Device recalled by DePuy Spine	DePuy Spine	Other	Nationwide
11 Apr 2018Device	CLASS II	Confidence Plus Kit Spinal Cement System, Product Codes: 283910000 recalled	DePuy Spine	Other	MA

Other Spinal Implants recalls

All 1,161

Reported	Class	Recall	Company	Reason	Where
21 Oct 2026Device	CLASS II	Medline surgical convenience kits labeled as: Spinal CDS recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026Device	CLASS II	Medline surgical convenience kits labeled as recalled	Medline Industries	Packaging Defects	Nationwide
30 Sep 2026Device	CLASS II	Extended Polyaxial Head, Attached Gimbal recalled	Seaspine Orthopedics	Other	Nationwide
30 Sep 2026Device	CLASS II	Medline Convenience Kits: Anterior Spine Pack recalled	Medline Industries	Other	Nationwide
9 Sep 2026Device	CLASS II	Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled	Avid Medical	Sterility	Nationwide