Encore Medical, Lp: Medical Device Recall in 2012 - (Recall #: Z-2302-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

3DKnee e+ Tibial Insert - HXLPE-VE, Sterile, Material: Highly cross linked vitamin E PE, Sz 2/9mm. The insert is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along lateral condyle. This insert is to be used along with the other components that comprise the 3DKnee System.

Product Classification:

Class II

Date Initiated: August 9, 2012

Date Posted: September 5, 2012

Recall Number: Z-2302-2012

Event ID: 62801

Reason for Recall:

The firm is recalling one lot of 392-09-706, 3DKnee e+ Tibial insert, 9 mm, Size 6, Right. The shelf life labeling of specific lots for a component were found to be incorrect and were found to be expired.

Status: Terminated

Product Quantity: 7 units

Code Information:

Model Number 392-09-706, Lot Number 59602519

Distribution Pattern:

Worldwide Distribution including Venezuela.

Voluntary or Mandated:

Voluntary: Firm initiated