Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-00-036
Recall
- Recall Number
- Z-1460-2026
- Event Number
- 98340
- FEI Number
- 1000116912
- Product Code
- PHX
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- January 15, 2026
- Posted
- February 24, 2026
- Address
- 9800 Metric Blvd, Encore Medical, LP, Austin, TX, 78758-5445
Description
Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-00-036
Knee and Humeral socket implants contain incorrect labeling.
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.
US Nationwide distribution in the states of VA, TN, IL, IN, MI, CO, WY, MT, RI, MA, NJ, PA, MO, OK, LA, FL, CA.
20 implants