Encore Medical, Lp: Medical Device Recall in 2013 - (Recall #: Z-1213-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 1, 2013

Date Posted: May 8, 2013

Recall Number: Z-1213-2013

Event ID: 64859

Reason for Recall:

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.

Status: Terminated

Product Quantity: 5

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.

Voluntary or Mandated:

Voluntary: Firm initiated