Reported Sep 5, 2012 · Terminated
3DKnee e+ Tibial Insert - HXLPE-VE, Sterile, Material: Highly cross linked vitamin E PE, Sz 2/9mm. The insert is…
Encore Medical, LP
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: Encore Medical, Lp · 9800 Metric Blvd · Austin, TX · 78758
Is this the product you have?
- 3DKnee e+ Tibial Insert - HXLPE-VE, Sterile
- MaterialHighly cross linked vitamin E PE, Sz 2/9mm. The insert is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along lateral condyle. This insert is to be used along with the other components that comprise the 3DKnee System
- Lot codes and dates
Model Number 392-09-706Lot Number 59602519
- Amount recalled
- 7 units
Why it was recalled
The firm is recalling one lot of 392-09-706, 3DKnee e+ Tibial insert, 9 mm, Size 6, Right. The shelf life labeling of specific lots for a component were found to be incorrect and were found to be expired.
This product could cause temporary or reversible health problems — stop using it.
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