DePuy Spine Recalls Confidence Plus Kit Spinal Cement System Lots
DePuy Spine is recalling specific lots of the Confidence Plus Kit Spinal Cement System because they may contain incorrect amounts of contrast medium, making the product difficult or impossible to visualize on x-ray.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product where the defect (inability to visualize cement on x-ray) could lead to injury, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
DePuy Spine, Inc. is recalling 1,972 units of the Confidence Plus Kit Spinal Cement System. The affected product codes are 283910000, associated with GTINs (01)10705034209623 and (01)10705034209630. The recall involves specific lot numbers listed in the agency's structured data, including 129385, 129386, and 133824 through 154957, as well as HVKBHH and HVKBHJ.
The recall is being conducted because certain lots of the spinal cement may contain incorrect amounts of contrast medium. This defect makes the product difficult or impossible to visualize on x-ray. The Confidence Spinal Cement System 11cc Kit is intended for percutaneous delivery of spinal cement, which is indicated for the fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures.
The affected units were distributed internationally outside the United States to Mexico, Canada, Ireland, Great Britain, Malaysia, Germany, Austria, Colombia, Spain, Switzerland, Australia, Hungary, Croatia, and Sweden. Healthcare providers and facilities that have received these specific lots should stop using the product and contact DePuy Spine for instructions on return or replacement.
The recalled product
- Product
- Confidence Plus Kit Spinal Cement System, Product Codes: 283910000 (GTIN: (01)10705034209623) and 283910000 (GTIN: (01)10705034209630) The CONFIDENCE SPINAL CEMENT SYSTEM¿ 11cc Kit is intended for percutaneous delivery of CONFIDENCE 11cc Spinal Cement, which is indicated for f
- Manufacturer
- DePuy Spine, Inc.
- Category
- Medical Device — Spinal Cement
- Affected units
- 1,972
Distribution
Distribution scope not specified by the agency.
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