Reported May 8, 2013 · Terminated
3DKnee e+ Tibial Insert. The insert is used along with the other components that comprise the 3DKnee System.
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. The insert is used along with the other components that comprise the 3DKnee System.
- Lot codes and dates
- Model/Catalog Number 391-15-708. Lot/Serial Number 59602230.
- Amount recalled
- 5
Where it was sold
Why it was recalled
U.S. Agent contacted Director Commercial Logistics, notifying him of incorrect color coded labels on two packages of e+tibial inserts. There were 8 e+ tibial inserts of the same lot number in Finished Goods as the two from the agency. These devices were inspected and all were incorrectly labeled.
This product could cause temporary or reversible health problems — stop using it.
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