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Confidence Spinal Cement System Kits
- Starting date:
- January 17, 2013
- Posting date:
- February 4, 2013
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices, Product Safety
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-17203
Recalled Products
- Confidence Plus Kit Spinal Cement
- Confidence Spinal Cement System Kit - (Needleless)
- Confidence Spinal Cement System Kit
Reason
DePuy Spine is recalling all lots of Confidence Kit Spinal Cement System and Confidence Plus Kit Spinal Cement System, following reports that the cement mixer used to prepare cement for surgery may not turn properly. The event may be described as the mixer being jammed or stuck.
Affected products
A. Confidence Plus Kit Spinal Cement
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
2839-10-000
Companies
- Manufacturer
- Depuy Spine
B. Confidence Spinal Cement System Kit - (Needleless)
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
2839-13-000
Companies
- Manufacturer
- Depuy Spine
C. Confidence Spinal Cement System Kit
Lot or serial number
- HNCCDZ
- HNDB09
- HNFBC6
- HNGB07
- HNGB8Z
- HNHB7W
- HNJBDG
- HNJBGH
Model or catalog number
- 2839-05-000
- 2839-07-000
Companies
- Manufacturer
- Depuy Spine