Recall record at a glance
| Official record | Z-2132-2013 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | DePuy Spine, Inc. |
| Report date | Sep 11, 2013 |
| Recall initiation date | Apr 17, 2013 |
| Quantity | 3896 units (Overall quantity distributed appears greater than quantities manufactured due to the distribution pathways) |
| Location | Raynham, MA, United States |
Official product description
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.
Why the product was 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.
Distribution information
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
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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