FDAFDA · Food and drugs·Recall number Z-1213-2013
3DKnee e+ Tibial Insert. The insert is used along with the other components that comprise the 3DKnee System.
Published May 8, 2013 · Recall initiated: April 1, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Encore Medical, Lp
- Distributor
- US Distribution to the state of California and International Distribution to the country of Venezuela.
- Lot
- Model/Catalog Number 391-15-708. Lot/Serial Number 59602230.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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