DePuy CONFIDENCE SPINAL CEMENT SYSTEM 11C Plus KIT Catalog Number:… — Class II medical device recall Z-0962-2013
Terminated recall by DePuy Spine, Inc., reported 2013-03-27, distributed nationwide. Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck
| Recall number | Z-0962-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DePuy Spine, Inc., Raynham, MA, United States |
| Recall initiated | 2013-01-15 |
| Classified | 2013-03-18 |
| Reported by FDA | 2013-03-27 |
| Terminated | 2014-06-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BR, CA, CH, CN, CO, CY, CZ, DE, ES, FI, FR, GB, GR, HK, HU, IE, IL, IN, IT, JO, LB, LU, LV, MX, MY, NL, NO, NZ, PL, PT, RU, SA, SE, SG, SI, SK, TR, UA, ZA |
| Quantity | 7,773 |
| Model numbers | 283910000 |
Product
DePuy CONFIDENCE SPINAL CEMENT SYSTEM 11C Plus KIT Catalog Number: 283910000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.
Reason for recall
Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck
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-0962-2013. 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.