FDA-Device2026-07-01Class IIPROCESSING DEFECT
Zimmer Off-Axis Comprehensive Shoulder System reamer guide recalled for breakage risk
Zimmer shoulder reamer guide recalled for breakage risk
The plastic guide in Zimmer's Off-Axis Comprehensive Shoulder System reamer tool can catch during the reaming procedure, causing it to break. The FDA received five complaints about this issue. No injuries have been reported.
- If you are a surgeon or surgical facility using this device, stop using the affected lots immediately.
- Contact Zimmer for instructions on how to return or replace the product.
- Check your inventory against the lot numbers: 099471, 099473, 099474, or 099475.
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
429 units
Manufactured in
1800 W Center St, N/A, Warsaw, IN, United States
Products
Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040242
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2529-2026More Zimmer Biomet recalls
- FDA-Device2026-07-01Zimmer Off-Axis Comprehensive Shoulder System Reamer Guide recalled for plastic breakage during surgery
- 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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