Zimmer Off-Axis Alliance Glenoid Reamer Guide Plastic Breakage Recall
Zimmer, Inc. is recalling the Off-Axis Alliance Glenoid Left 4-Peg Augment Reamer Guide because the plastic guides can catch during reaming and break. Five complaints have been received.
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: This is an FDA Class II recall of a surgical device with a risk-of-harm hazard (plastic breakage during a surgical procedure). The source explicitly documents five complaints but does not report any actual injuries or illnesses. Per the rubric, risk-of-harm products where injury has not yet been reported merit a score of 3.
Plain-English summary
Zimmer, Inc. is recalling the Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog Number 110040444. The device is used in shoulder surgery.
The recall was initiated because the plastic guides can catch during the reaming procedure, leading to breakage. Five complaints have been received identifying this issue.
The recalled device was distributed nationwide in the United States. The lot code is 110040444, UDI-DI is (01)00889024681903(17)350531(10)097487, and Lot Number is 097487. A total of 11 units were distributed.
Customers and healthcare providers who have this device should contact Zimmer, Inc. for instructions on replacement or alternative measures.
The recalled product
- Product
- Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040444
- Manufacturer
- Zimmer, Inc.
- Affected units
- 11
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: 110040444
- UDI-DI (01)00889024681903(17)350531(10)097487
- Lot Number 097487
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.
See all 5 products in this recall →Related recalls
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