FDA Device recall Z-2700-2026
Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 342-19-703 Product Description: Enovis knee…
- FDA Device
- Class II
- ongoing
- Published 2026-07-15
On 2026-07-15 the FDA classified a Class II recall of Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 342-19-703 Product Description: Enovis knee… by Encore Medical, citing due to packaging discrepancy with incorrect product size mixed up.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2700-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-02-16 |
| Published | 2026-07-15 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Encore Medical |
| Distribution | AL, CO, IA, IL, IN, MI, MT, NC, NE, NY, SD, TX, WY |
Product
Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 342-19-703 Product Description: Enovis knee devices are intended for knee arthroplasty.
Reason
Due to packaging discrepancy with incorrect product size mixed up.
Identifiers
| code_info | Model/Catalog Number: 342-19-703 Lot Code: Lot: 177T1057 GTIN: 00888912167703 Expiration Date: 12/07/2026 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Other recalls by Encore Medical
- Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 341-14-711 Product Description: Enovis knee…
FDA Device · Class II · 2026-07-15 · Encore Medical - Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus Model/Catalog Number: 5…
FDA Device · Class II · 2026-03-04 · Encore Medical - Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-00…
FDA Device · Class II · 2026-03-04 · Encore Medical - Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Number: 341-16-707
FDA Device · Class II · 2026-03-04 · Encore Medical - EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
FDA Device · Class II · 2026-02-11 · Encore Medical
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2700-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.