FDA-Device2013-05-08Class II
3DKnee e+ Tibial Insert. The insert is used along with the other components that comprise the 3DKnee System.
Encore Medical, Lp
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.
Sold states
US Distribution to the state of California and International Distribution to the country of Venezuela.
Affected count
5
Manufactured in
9800 Metric Blvd, Austin, TX, United States
Products
3DKnee e+ Tibial Insert. The insert is used along with the other components that comprise the 3DKnee System.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1213-2013Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief