Recall Z-1460-2026
Encore Medical, LP · initiated January 15, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-00-036
Codes / lots: Lot Code: Lot: 378P1382 GTIN: 00888912144544
Reason for recall
Knee and Humeral socket implants contain incorrect labeling.
FDA-determined cause: Process control
Action taken
On January 16, 2026 Enovis (Encore Medical, L.P.) issued an Urgent: Medical Device Recall Expansion notification via E-Mail. The expansion was conducted to include additional products. The original notice was issued on July 9, 2025 Enovis is asking consignees to take the following actions 1. Review your stock for the products and lot numbers for the items to be returned. 2. Remove any product from stock and quarantine. 3. This notice needs to be passed on to all those within your organization or to any organization where the product has been transferred. 4. Complete acknowledgement and response form and contact Customer Service at 1-800-456-8696 or through your regional email. 5. Return all devices (quantities listed above) using the RMA number and shipping label provided by Customer Service.
Details
- Recall number
- Z-1460-2026
- Initiated
- January 15, 2026
- Posted by FDA
- February 24, 2026
- Product code
- PHX – Shoulder Prosthesis, Reverse Configuration
- Quantity
- 20 implants
- Distribution
- US Nationwide distribution in the states of VA, TN, IL, IN, MI, CO, WY, MT, RI, MA, NJ, PA, MO, OK, LA, FL, CA.
- Recalling firm
- Encore Medical, LP, Austin, TX
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1458-2026 Class II | Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT…Knee and Humeral socket implants contain incorrect labeling. | 01/15/2026Open, Classified |
| Z-1459-2026 Class II | Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog…Knee and Humeral socket implants contain incorrect labeling. | 01/15/2026Open, Classified |