Encore Medical, Lp: Medical Device Recall in 2018 - (Recall #: Z-2967-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Foundation Modular Femoral Stem, Part Number, 220-10-110. Knee prosthesis component. The Foundation Revision Knee is a total knee system indicated as knee joint replacement for patients suffering from pain and dysfunction.

Product Classification:

Class II

Date Initiated: May 14, 2018

Date Posted: September 12, 2018

Recall Number: Z-2967-2018

Event ID: 80692

Reason for Recall:

After receipt of a product complaint for the labeling, it was determined that this device does not have FDA clearance.

Status: Terminated

Product Quantity: 12

Code Information:

All. Lots-866A1011, 866A1022

Distribution Pattern:

U.S. Distribution to states of: AZ, MO, MS, NY, OK, and UT; internationally to: Japan.

Voluntary or Mandated:

Voluntary: Firm initiated