Class II

Medical Device Recall: Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210

FX SHOULDER · August 8, 2023

Reason for Recall

Centered glenosphere box may contain an eccentric glenosphere.

Distribution

US Nationwide distribution in the state of NJ.

States Affected

NATIONWIDE

Quantity Affected

4

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0843-2024

Status: ongoing

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.

FX SHOULDER Medical Device Recall: Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210 | SafeCheck