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.
What this means for you
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.
- Hazard
- device-breakage
- surgical-complication
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.
Related recalls
Same category
- HighPhilips Avalon Fetal Monitor FM 30 Speaker Connector Assembly
FDA (Devices) · 2026-07-01
- SevereDa Vinci surgical system operative components with E-brake retainer pin defect
FDA (Devices) · 2026-07-01
- ModerateOctopus Evolution AS Tissue Stabilizer Model TS2500 Tubing Assembly Issue Recall
FDA (Devices) · 2026-07-01
- ModerateOctopus 4 Tissue Stabilizer incorrectly assembled tubing positions
FDA (Devices) · 2026-07-01
- ModerateMedline Polycarbonate Syringes in Convenience Kits Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01