Class II — DePuy Spine, Inc.
| Recalling firm | DePuy Spine, Inc. |
|---|---|
| Registered facility | DEPUY SPINE, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck |
| 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. |
| Quantity | 7773 |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of Argentina, Armenia, Kazakhstan, Russia, Ukraine, Australia, Austria Belgium, Luxembourg , Brazil, Canada, China, Colombia, Cyprus, Jordan Lebanon, Saudi Arabia, UAE, Czech Republic, Finland ,France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Latvia, Malaysia Mexico, Netherlands, New Zealand, Norway, Sweden, Polan… |
| Initiated | 2013-01-15 |
| Classified | 2013-03-18 |
| Terminated | 2014-06-30 |
| Recall number | Z-0962-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — DePuy Spine, Inc. (Z-0962-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/64072/
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