Recall Z-2529-2026— Zimmer, Inc.

Name: FDA recall Z-2529-2026
Creator: U.S. Food and Drug Administration
Published: 2026-05-20

Class II · Ongoing

Class II FDA medical device recall by Zimmer, Inc., initiated 2026-05-20. It names one FDA 510(k) clearance: K241043. Product: Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040242. Reason: Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage..

Recalling firm: Zimmer, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2026-05-20
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K241043 — Augment Off-Axis Instrument SystemFix Surgical·cleared 2024-05-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.