Confidence Plus Kit Spinal Cement System — Class II medical device recall Z-1300-2018
Terminated recall by DePuy Spine, Inc., reported 2018-04-11. Certain lots of the spinal cement may contain incorrect amounts of contrast medium so that the product is diff
| Recall number | Z-1300-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DePuy Spine, Inc., Raynham, MA, United States |
| Recall initiated | 2017-12-15 |
| Classified | 2018-04-03 |
| Reported by FDA | 2018-04-11 |
| Terminated | 2020-04-13 |
| Countries outside the US | AT, AU, CA, CH, CO, DE, ES, GB, HR, HU, IE, MX, MY, SE |
| Quantity | 1,972 |
| UPC / GTIN / UDI-DI | 10705034209623, 10705034209630 |
| 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 and 2 more |
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 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).
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1300-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.