Food, drugs, devices › Integra LifeSciences Corp.
Device recall: Integra External Fixation System Rocker Bottom Model # 12225400. For use in the treatment of bone conditions amenable to
Integra LifeSciences Corp. (Plainsboro, NJ) initiated this device recall on 1 Jul 2016; FDA lists 1 product record under event 74583, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,232 device enforcement events initiated in 2016 carry the same class.
Status: Terminated, terminated 16 Dec 2016. Initiation: voluntary: firm initiated. Integra LifeSciences Corp. has 79 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Integra LifeSciences Corp., Plainsboro, NJ.
Reason for recall
"The silicone insert embedded in the rocker bottom has the potential to become dislodged or loose from the rocker bottom mold."
Distribution
"Distributed in the US to the states of FL, VA, OK, CO, DC, and IN."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2296-2016 | 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. | 27 units | Class II | Terminated | 3 Aug 2016 |
Context
Other enforcement events for Integra LifeSciences Corp.
All 79 events for Integra LifeSciences Corp.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The silicone insert embedded in the rocker bottom has the potential to become dislodged or loose from the rocker bottom mold."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Distributed in the US to the states of FL, VA, OK, CO, DC, and IN."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 16 Dec 2016. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.