||May 02, 2013
||3DKnee e+ Tibial Insert. The insert is used along with the other components that comprise the 3DKnee System.
||Model/Catalog Number 391-15-708. Lot/Serial Number 59602230.
|Encore Medical, Lp
9800 Metric Blvd
Austin, Texas 78758
|For Additional Information Contact
|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.
||The firm sent their US customer a "Urgent Field Safety Notice" letter on April 1, 2013. The letter explained the product problem and provided recommended actions as well as customer contact numbers.
|Quantity in Commerce
||US Distribution to the state of California and International Distribution to the country of Venezuela.