Reported Apr 11, 2018 · Terminated
Confidence Plus Kit Spinal Cement System, Product Codes: 283910000 (GTIN: (01)10705034209623) and 283910000 (GTIN:…
DePuy Spine, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: DePuy Spine, Inc. · 325 Paramount Dr · Raynham, MA · 02767-5199
Is this the product you have?
- Confidence Plus Kit Spinal Cement System
- Product Codes283910000 (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 fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancer, myeloma)
- Lot codes and dates
- Lot numbersHVKBHH HVKBHJ
129385129386133824133825133826133827133828133829133830133831134609134610134611134612134613134614135476135477135478145664145665145666145667145668145669145670145671147555152905152906152908153880153881153882153883153884153885153886153888153889154956154957
- Lot numbers
- Amount recalled
- 1972
Why it was recalled
Certain lots of the spinal cement may contain incorrect amounts of contrast medium so that the product is difficult or impossible to visualize on x-ray.
This product could cause temporary or reversible health problems — stop using it.
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