Class II

Medical Device Recall: Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241

Zimmer, Inc. · May 20, 2026

Reason for Recall

Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

Distribution

US Nationwide distribution.

States Affected

NATIONWIDE

Quantity Affected

435 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2528-2026

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.

Zimmer, Inc. Medical Device Recall: Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241 | SafeCheck