Zimmer Off-Axis Alliance Glenoid Reamer Guide recalled for breakage
Zimmer is recalling the Off-Axis Alliance Glenoid Right 4-Peg Augment Reamer Guide (Model 110040476) after five complaints that plastic guides broke during reaming.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II device recall where a structural defect (plastic guide breakage) could compromise device function during surgery. No illnesses or injuries are reported in the source text, but the hazard is real and involves a surgical instrument where malfunction poses a risk of patient harm.
Plain-English summary
Zimmer, Inc. is recalling the Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide (Model/Catalog Number 110040476) due to a device defect affecting its function.
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage. This could affect the proper function of the device during surgical use.
The affected lot is Lot Number 097492 (UDI-DI: 01-00889024682047-17-350531-10-097492), with 13 units distributed nationwide in the United States. Healthcare facilities and practitioners who have received this product should stop using affected units and contact Zimmer, Inc. for further instructions regarding return or replacement.
The recalled product
- Product
- Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040476
- Manufacturer
- Zimmer, Inc.
- Affected units
- 13
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot Code: Model No. 110040476
- UDI-DI (01)00889024682047(17)350531(10)097492
- Lot Number 097492
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Zimmer, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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