Class II

Medical Device Recall: Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm, Semi-Constrained, Sterile H2o2, CE 2797

Encore Medical, LP · October 5, 2023

Reason for Recall

Mislabeling

Distribution

US Nationwide distribution in the states of VA, TN, MN, IN, RI, ME, TX, LA, AL, FL, CA.

States Affected

NATIONWIDE

Quantity Affected

17 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0625-2024

Status: completed

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Encore Medical, LP Medical Device Recall: Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm, Semi-Constrained, Sterile H2o2, CE 2797 | SafeCheck