RecallRadar

FDA Device recall Z-2701-2026

Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 341-14-711 Product Description: Enovis knee…

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: 341-14-711 Product Description: Enovis knee… by Encore Medical, citing due to packaging discrepancy with incorrect product size mixed up.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2701-2026
ClassificationClass II
Statusongoing
Initiated2026-02-16
Published2026-07-15
Last updated2026-09-13 11:58 UTC
CompanyEncore Medical
DistributionAL, 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: 341-14-711 Product Description: Enovis knee devices are for knee arthroplasty.

Reason

Due to packaging discrepancy with incorrect product size mixed up.

Identifiers

code_infoModel/Catalog Number: 341-14-711 Lot Code: Lot: 145T1067 and 135T1060 GTIN: 00888912167086 Expiration Date: 12-06-2026 (145T1067) 12-07-2026 (135T1060)

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2701-2026%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.