FDA Device recall Z-0103-2024
EMPOWR Acetabular System, Liner, 10¿ Hooded, HXe+, 40H, REF: 942-01-40H
- FDA Device
- Class II
- ongoing
- Published 2023-10-18
On 2023-10-18 the FDA classified a Class II recall of EMPOWR Acetabular System, Liner, 10¿ Hooded, HXe+, 40H, REF: 942-01-40H by Encore Medical, citing knee insert and acetabular system parts were swapped within inner pack prior to the product being sealed within the tray, which could result in surgeons not having the correct pro….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0103-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-08-22 |
| Published | 2023-10-18 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Encore Medical |
| Distribution | US |
Product
EMPOWR Acetabular System, Liner, 10¿ Hooded, HXe+, 40H, REF: 942-01-40H
Reason
Knee insert and acetabular system parts were swapped within inner pack prior to the product being sealed within the tray, which could result in surgeons not having the correct product for the surgery due to different anatomies (Hip vs Knee).
Identifiers
| code_info | UDI-DI: 00190446309833, Lot: 629Z1114, Expiration: March 30, 2028 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 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: 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 · 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
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0103-2024%22
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