FDA Device recall Z-2296-2016
Integra External Fixation System Rocker Bottom Model # 12225400
- FDA Device
- Class II
- terminated
- Published 2016-08-03
On 2016-08-03 the FDA classified a Class II recall of Integra External Fixation System Rocker Bottom Model # 12225400 by Integra Lifesciences, citing the silicone insert embedded in the rocker bottom has the potential to become dislodged or loose from the rocker bottom mold.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2296-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-07-01 |
| Published | 2016-08-03 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Integra Lifesciences |
| Distribution | CO, DC, FL, IN, OK, VA |
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.
Reason
The silicone insert embedded in the rocker bottom has the potential to become dislodged or loose from the rocker bottom mold.
Identifiers
| code_info | Lot # PN625. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2296-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.