Class II — Integra LifeSciences Corp.
| Recalling firm | Integra LifeSciences Corporation |
|---|---|
| Registered facility | View this company's 15 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The silicone insert embedded in the rocker bottom has the potential to become dislodged or loose from the rocker bottom mold. |
| Product | Integra External Fixation System Rocker Bottom Model # 12225400. For use in the treatment of bone conditions amenable to treatment by the use of external fixation. |
| Quantity | 27 units |
| Distribution | Distributed in the US to the states of FL, VA, OK, CO, DC, and IN. |
| Initiated | 2016-07-01 |
| Classified | 2016-07-27 |
| Terminated | 2016-12-16 |
| Recall number | Z-2296-2016 |
| 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 — Integra LifeSciences Corp. (Z-2296-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/74583/
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