CLASS II Device recall · Reported 11 Sep 2013 · FDA Enforcement Report
Confidence Spinal Cement System 5CC Kit, Product recalled by DePuy Spine
DePuy Spine is recalling Confidence Spinal Cement System 5CC Kit, Product, distributed in 33 states. The recall was initiated on 17 Apr 2013 and the FDA has classified it as Class II.
Check your package
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-2132-2013
- FDA event ID
- 64937
- Recalling firm
- DePuy Spine, Raynham, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Apr 2013
- FDA classified
- 3 Sep 2013
- Reported
- 11 Sep 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Spinal Implants
Timeline
| 17 Apr 2013 | Recall initiated by company | |
| 3 Sep 2013 | Classified by FDA | +139 days |
| 11 Sep 2013 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
During injection of cement, the water in the hydraulic pump leaks past the piston within the pump body resulting in the loss of pressure and inability to continue to inject cement.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT, Product Code: 2839-05-000 The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures.
Where it was distributed
Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IN, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WV, WY; Worldwide: Algeria, Australia, Austria, Belgium, Brazil, Canada, Colombia, Cyprus, Czech Republic, France, Germany, Hong Kong, India, Israel, Italy, Latvia, Luxembourg, Malaysia, Mexico, Netherlands, Norway, Poland, Portugal, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, UAE, and UK
ArkansasArizonaCaliforniaColoradoConnecticutFloridaGeorgiaHawaiiIowaIdahoIndianaKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouriNorth CarolinaNebraska
Questions about this recall
Is Confidence Spinal Cement System 5CC Kit, Product recalled?
Yes. DePuy Spine recalled Confidence Spinal Cement System 5CC Kit, Product on 17 Apr 2013. The recall is Class II and its status is Terminated. Recall number Z-2132-2013.
Why was it recalled?
During injection of cement, the water in the hydraulic pump leaks past the piston within the pump body resulting in the loss of pressure and inability to continue to inject cement.
Which lots are affected?
HPBBZP, HPDBFZ
Where was it sold?
Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IN, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WV, WY; Worldwide: Algeria, Australia, Austria, Belgium, Brazil, Canada, Colombia, Cyprus, Czech Republic, France, Germany, Hong Kong, India, Israel, Italy, Latvia, Luxembourg, Malaysia, Mexico, Netherlands, Norway, Poland, Portugal, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, UAE, and UK
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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| Device | CLASS II | Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled | AVID Medical | Sterility | Nationwide |
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