Z-1458-2026 Class II Ongoing
FDA device recall Z-1458-2026 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 HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus Model/Catalog Number: 509-00-432
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: 385P1263 GTIN: 00888912144575
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1458-2026
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026