Encore Medical, Lp: Medical Device Recall in 2017 - (Recall #: Z-2658-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

3DKNEE(TM) SYSTEM e+, tibial Insert, LEFT Sz 6 / 11mm, REF 391-11-706, QTY 01, The 3DKnee Insert HXL Tibial Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to conform to ASTM F2695. This insert is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along the lateral condyle.

Product Classification:

Class II

Date Initiated: May 31, 2017

Date Posted: July 12, 2017

Recall Number: Z-2658-2017

Event ID: 77435

Reason for Recall:

Mis-pack. A size 6 Left 3DKnee Tibial Insert box and pouch contained a Size 8 right 3Dknee Tibial Insert.

Status: Terminated

Product Quantity: 9 units

Code Information:

Lot # 292G1910

Distribution Pattern:

Worldwide Distribution-US (nationwide) to states of: AL, TX, UT, and CA; and countries of: INDIA and GERMANY.

Voluntary or Mandated:

Voluntary: Firm initiated