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Open, Classified

DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 Left 3D MATRIX COATED REF 243-01-108 DJO surgical EMPOWR KNEE", PRESS FIT BP MINUS, 8L REF 353-03-108 For the treatment of patients who are candidates for knee arthroplasty per the Indication for use.

FDA Recall Z-0508-2024 · Posted 2023-12-07

Recalling FirmEncore Medical, LP
Recall StatusOpen, Classified
Product CodeMBH
Date Initiated2023-11-10
Product Quantity37 devices

Reason for Recall

Due to incorrect product/device within packaging.

Root Cause

Labeling Change Control

Distribution Pattern

US Nationwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K171991EMPOWR Porous Knee SystemEncore Medical L.P. · 2017-10-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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