FDA-Device2026-07-01Class II
Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040444
Hazard
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Sold states
US Nationwide distribution.
Affected count
11 units
Manufactured in
1800 W Center St, N/A, Warsaw, IN, United States
Products
Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040444
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2530-2026More Zimmer, Inc. recalls
- FDA-Device2026-07-01Zimmer Off-Axis Comprehensive Shoulder System reamer guide recalled for breakage risk
- FDA-Device2026-07-01Zimmer Off-Axis Alliance Glenoid Reamer Guide recalled for plastic breakage risk during surgery
- FDA-Device2026-07-01Zimmer Persona Revision Femoral Distal Augment recalled for wrong component in package
- FDA-Device2026-07-01Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040242
- FDA-Device2026-07-01Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240
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