Home / Recalls / Encore Medical, LP / Z-0282-2024

Z-0282-2024 Class II Ongoing

Recalled by Encore Medical, LP — Austin, TX

Recall Details

Product Type: Devices
Report Date: November 15, 2023
Initiation Date: September 25, 2023
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 20

Product Description

RSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm, REF: 509-01-436, orthopedic shoulder implant component.

Reason for Recall

Two different humeral socket Insert devices were swapped during packaging, which could result in surgeons not having the correct device for surgery, which could cause a delay in surgery.

Distribution Pattern

US: MN, TX, IN, OH, SC, RI, ME, NJ, NY, KS, LA, FL, CA

Code Information

UDI-DI: 00888912144667, Lot: 390P1157

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)