Home / Recalls / Encore Medical, LP / Z-1460-2026

Z-1460-2026 Class II Ongoing

Recalled by Encore Medical, LP — Austin, TX

FDA device recall Z-1460-2026 was initiated by Encore Medical, LP on Jan 15, 2026 and is designated Class II. Reason for recall: Knee and Humeral socket implants contain incorrect labeling. The recall status is ongoing. Affected quantity: 20 implants.

Recall details

Product Type: Devices
Report Date: Mar 4, 2026
Initiation Date: Jan 15, 2026
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 20 implants

Product description

Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-00-036

Reason for recall

Knee and Humeral socket implants contain incorrect labeling.

Distribution pattern

US Nationwide distribution in the states of VA, TN, IL, IN, MI, CO, WY, MT, RI, MA, NJ, PA, MO, OK, LA, FL, CA.

Code information

Lot Code: Lot: 378P1382 GTIN: 00888912144544

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-1460-2026
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Other recalls by Encore Medical, LP

Z-2701-2026 Class II — Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE… (Feb 16, 2026)
Z-2700-2026 Class II — Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE… (Feb 16, 2026)
Z-1459-2026 Class II — Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE… (Jan 15, 2026)
Z-1458-2026 Class II — Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET… (Jan 15, 2026)
Z-1233-2026 Class II — EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705 (Jan 5, 2026)
Z-1234-2026 Class II — EMPOWR Acetabular System: Liner, 10 degree Hooded, HXe+, 36H, REF: 942-01-36H… (Jan 5, 2026)
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