CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT — Class II medical device recall Z-2132-2013
Terminated recall by DePuy Spine, Inc., reported 2013-09-11, distributed in AR, AZ, CA, CO, CT, FL, GA, HI…. During injection of cement, the water in the hydraulic pump leaks past the piston within the pump body resulti
| Recall number | Z-2132-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DePuy Spine, Inc., Raynham, MA, United States |
| Recall initiated | 2013-04-17 |
| Classified | 2013-09-03 |
| Reported by FDA | 2013-09-11 |
| Terminated | 2014-08-13 |
| Distributed | AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IN, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WV, WY |
| Countries outside the US | AE, AT, AU, BE, BR, CA, CH, CO, CY, CZ, DE, DZ, ES, FR, GB, HK, IL, IN, IT, LU, LV, MX, MY, NL, NO, PL, PT, SE, SG, SI, TR, ZA |
| Quantity | 3,896 units |
| Reason classes | packaging |
Product
CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT, Product Code: 2839-05-000 The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures.
Reason for recall
During injection of cement, the water in the hydraulic pump leaks past the piston within the pump body resulting in the loss of pressure and inability to continue to inject cement.
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-2132-2013. 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.