Encore Medical, LP: Medical Device Recall in 2021 - (Recall #: Z-2104-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-16-711 Left Sz. 11 16mm, CE 0086, Sterile H2O2, UDI: (01)00888912167185

Product Classification:

Class II

Date Initiated: May 12, 2021

Date Posted: July 28, 2021

Recall Number: Z-2104-2021

Event ID: 87942

Reason for Recall:

Packaging mixup; There is a potential that packaging identified as 12mm knee prosthesis contains 16mm knee prosthesis and 16mm knee prosthesis packaging contains 12 mm knee prosthesis.

Status: Ongoing

Product Quantity: 10 units

Code Information:

Lot # 155T1035

Distribution Pattern:

US: Nationwide Distribution in the states of VA, MN, TX, IL, MS, CA, KS, LA, and GA OUS: None

Voluntary or Mandated:

Voluntary: Firm initiated