FDA-Device2026-07-01Class IIPROCESSING DEFECT
Zimmer Off-Axis Comprehensive Shoulder System reamer guide recalled for breakage risk
OTHERNationwide distribution
Zimmer shoulder reamer guide recalled for breakage risk
Zimmer has recalled a plastic reamer guide used during shoulder surgery due to reports of the guide catching and breaking during the reaming procedure. Five complaints have been received. No injuries have been reported.
- If you have one of the affected lot numbers (099463, 099464, 099465, or 099467), stop using it and contact Zimmer for instructions.
- Contact your surgical facility or Zimmer if you have questions about whether you have an affected unit.
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
435 units
Manufactured in
1800 W Center St, N/A, Warsaw, IN, United States
Products
Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2528-2026More Zimmer, Inc. recalls
- 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 Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040444
- 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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