Recall Z-1458-2026 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Encore Medical, LP
Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus Model/Catalog Number: 509-00-432
| Date | Feb 24, 2026 (initiated Jan 15, 2026) |
| Status | Open, Classified |
| Reason | Knee and Humeral socket implants contain incorrect labeling. |
| Root cause | Process control |
| Action | 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 respon |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100741 | REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM, REVERSE SHOULDER PROSTHESIS HUMERAL INSERTS, MODEL 510-00-006/012 Encore Medical L.P., Aug 2, 2010 |