Home / Recalls / Encore Medical, LP / Z-0098-2024

Z-0098-2024 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: 70

Product Description

REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, REF: 506-03-130

Reason for Recall

Reverse shoulder prosthesis package that should contain 5mmx30 screws could contain incorrect 3.5mmx30 screws. Use of incorrect screws could result in surgical delay and inadequate fixation.

Distribution Pattern

US: FL, IN, WI, IA, MN, KY, NY, AZ, RI, WA, OH, SC, VA, TX. OUS: MX

Code Information

UDI-DI: 00888912024570, Lot: 835C2074, EXP: 2029-03-9

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)