3DKnee e+ Tibial Insert. The insert is used along with the other components that comprise the 3DKnee System.

Reason: 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.

Code information: Model/Catalog Number 391-15-708. Lot/Serial Number 59602230.

Distribution pattern: US Distribution to the state of California and International Distribution to the country of Venezuela.