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U.S. Department of Health and Human Services

Enforcement Report - Week of May 8, 2013

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Event Detail

Event ID 64859
Product Type Devices
Status Ongoing
Recalling Firm Encore Medical, Lp
City Austin
State TX
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-04-01
Initial Firm Notification of
Consignee or Public
Distribution Pattern US Distribution to the state of California and International Distribution to the country of Venezuela.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Class II 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. 5 Z-1213-2013