FDA-Device2026-07-01Class IIPROCESSING DEFECT
Zimmer Off-Axis Comprehensive Shoulder System reamer guide recalled for breakage risk
What this means
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.
The agency's original wording
Hazard
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Intended for
Adults
Illnesses reported
None reported
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-2528-2026Want us to check the next one for you?
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