FDA-Device2026-07-01Class IIPROCESSING DEFECT
Zimmer Off-Axis Alliance Glenoid Reamer Guide recalled for plastic breakage risk during surgery
What this means
Zimmer identified a defect in the Off-Axis Alliance Glenoid Reamer Guide where plastic components can catch and break during the reaming procedure. Five complaints of this issue have been reported. The affected surgical instrument was distributed nationwide, with 13 units involved.
- If you have this reamer guide (Model 110040476, Lot 097492), contact your Zimmer sales representative or the device manufacturer for guidance
- Do not use the device if you suspect it may be affected
- Report any incidents involving this device to Zimmer and the FDA
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
13 units
Manufactured in
1800 W Center St, N/A, Warsaw, IN, United States
Products
Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040476
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2531-2026Want us to check the next one for you?
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