Reported Aug 3, 2016 · Terminated
Integra External Fixation System Rocker Bottom Model # 12225400. For use in the treatment of bone conditions amenable…
Integra LifeSciences Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Integra LifeSciences Corp. · 311 Enterprise Dr · Plainsboro, NJ · 08536-3344
Is this the product you have?
- 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.
- Lot codes and dates
- Lot # PN625.
- Amount recalled
- 27 units
Where it was sold
Why it was recalled
The silicone insert embedded in the rocker bottom has the potential to become dislodged or loose from the rocker bottom mold.
This product could cause temporary or reversible health problems — stop using it.
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