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Encore Medical, Lp recalls 3DKnee e+ Tibial Insert. The insert is used along with the other components that comprise the 3DKnee System.
Recalled May 8, 2013 · FDA recall Z-1213-2013 · Encore Medical
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. · FDA Class II
Units
5
Sold at
US Distribution to the state of California and International Distribution to the country of Venezuela.
Description
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.
Product
3DKnee e+ Tibial Insert. The insert is used along with the other components that comprise the 3DKnee System.
Manufacturer(s)
Encore Medical, Lp
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →