FDA-Device2026-07-01Class IIPROCESSING DEFECT
Zimmer Off-Axis Comprehensive Shoulder System reamer guide recalled for breakage risk
What this means
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.
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
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-2529-2026Want us to check the next one for you?
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