Integra External Fixation System Rocker Bottom Model # 12225400 — Class II medical device recall Z-2296-2016
Terminated recall by Integra LifeSciences Corp., reported 2016-08-03, distributed in CO, DC, FL, IN, OK, VA. The silicone insert embedded in the rocker bottom has the potential to become dislodged or loose from the rock
| Recall number | Z-2296-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp., Plainsboro, NJ, United States |
| Recall initiated | 2016-07-01 |
| Classified | 2016-07-27 |
| Reported by FDA | 2016-08-03 |
| Terminated | 2016-12-16 |
| Distributed | CO, DC, FL, IN, OK, VA |
| Quantity | 27 units |
| Reason classes | microbial contamination |
| Pathogens | mold |
| Lot numbers | PN625 |
| Model numbers | 12225400 |
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 for recall
The silicone insert embedded in the rocker bottom has the potential to become dislodged or loose from the rocker bottom mold.
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-2296-2016. 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.