FDA recall Z-2529-2026

Zimmer, Inc. · Class II · device

Product

Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040242

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.

Key facts

Status
Ongoing
Initiation date
2026-05-20
Report date
2026-07-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2529-2026