Home / Recalls / Encore Medical, LP / Z-0103-2024

Z-0103-2024 Class II Ongoing

Recalled by Encore Medical, LP — Austin, TX

Recall Details

Product Type
Devices
Report Date
October 18, 2023
Initiation Date
August 22, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
20

Product Description

EMPOWR Acetabular System, Liner, 10¿ Hooded, HXe+, 40H, REF: 942-01-40H

Reason for Recall

Knee insert and acetabular system parts were swapped within inner pack prior to the product being sealed within the tray, which could result in surgeons not having the correct product for the surgery due to different anatomies (Hip vs Knee).

Distribution Pattern

US Nationwide distribution in the states of FL, CA, IN, HI, LA, MN, AZ, TX, NJ, PA, KS, TN, PR, SC, WA.

Code Information

UDI-DI: 00190446309833, Lot: 629Z1114, Expiration: March 30, 2028

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)