Home / Recalls / Encore Medical, LP / Z-2104-2021

Z-2104-2021 Class II Ongoing

Recalled by Encore Medical, LP — Austin, TX

Recall Details

Product Type: Devices
Report Date: July 28, 2021
Initiation Date: May 12, 2021
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 10 units

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

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.

Distribution Pattern

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

Code Information

Lot # 155T1035

Other recalls by Encore Medical, LP

Z-1460-2026 Class II — Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERA (January 15, 2026)
Z-1459-2026 Class II — Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model (January 15, 2026)
Z-1458-2026 Class II — Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET (January 15, 2026)
Z-1233-2026 Class II — EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705 (January 5, 2026)
Z-1234-2026 Class II — EMPOWR Acetabular System: Liner, 10 degree Hooded, HXe+, 36H, REF: 942-01-36H; L (January 5, 2026)
Z-2548-2025 Class II — Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER SL (July 18, 2025)
Z-2546-2025 Class II — Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER HE (July 18, 2025)
Z-2549-2025 Class II — Brand Name: DJO SURGICAL Product Name: FA S Altivate Reverse Glenoid Tray Mode (July 18, 2025)
Z-2547-2025 Class II — Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER BO (July 18, 2025)
Z-2286-2025 Class II — Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE I (July 9, 2025)