Confidence Plus Kit Spinal Cement System recall
Confidence Plus Kit Spinal Cement System, Product Codes: 283910000 (GTIN: (01)10705034209623) and 283910000 (GTIN: (01)10705034209630) The CONFIDENCE…
Why was Confidence Plus Kit Spinal Cement System 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot numbers: 129385 129386 133824 133825 133826 133827 133828 133829 133830 133831 134609 134610 134611 134612 134613 134614 135476 135477 135478 145664 145665 145666 145667 145668 145669 145670 145671 147555 152905 152906 152908 153880 153881 153882 153883 153884 153885 153886 153888 153889 154956 154957 HVKBHH HVKBHJ
- Product
- Confidence Plus Kit Spinal Cement System, Product Codes: 283910000 (GTIN: (01)10705034209623) and 283910000 (GTIN: (01)10705034209630) The CONFIDENCE…
- Recalling firm
- DePuy Spine, Inc.
- Quantity
- 1972
- Distribution
- International Distribution (outside the U.S.) only: Mexico, Canada, Ireland, Great Britain, Malaysia, Germany, Austria, Colombia, Spain, Austria, Switzerland, Australia, Hungary, Croatia, and Sweden.
- Recall date
- April 11, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)