FDA-Device2026-07-01Class IIPROCESSING DEFECT
Zimmer Off-Axis Comprehensive Shoulder System Reamer Guide recalled for plastic breakage during surgery
Zimmer shoulder reamer guide recalled for breakage risk
Zimmer has recalled a plastic reamer guide used in shoulder surgery because the plastic can catch and break during the reaming procedure. Five complaints have been received describing this issue. No injuries have been reported.
- Contact Zimmer if you have this device in stock or in use.
- Review the lot numbers 099457 and 099458 to identify affected units.
- Do not use affected guides until you receive further instructions from Zimmer.
Hazard
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Who it affects
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
474 units
Manufactured in
1800 W Center St, N/A, Warsaw, IN, United States
Products
Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2527-2026More Zimmer Biomet 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 breakage during surgery
- FDA-Device2026-07-01Zimmer Persona Revision Femoral Distal Augment recalled for wrong component in package
- FDA-Device2026-07-01Zimmer Off-Axis Alliance Glenoid Reamer Guide recalled for plastic breakage risk during surgery
- FDA-Device2026-07-01Zimmer Off-Axis Comprehensive Shoulder System reamer guide recalled for breakage risk
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