FDA recall, , Moderate risk
Zimmer Off-Axis Comprehensive Shoulder System Reamer Guides
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Summary by Recall Canary from the FDA notice
What happened
Zimmer, Inc. of Warsaw, Indiana, recalled the Off-Axis Comprehensive Shoulder System and Off-Axis Alliance Glenoid reamer guides, including the Medium, Small, and Large Augment Off-Axis Reamer Guides and the Right and Left 4-Peg Augment Reamer Guides. The recall was initiated May 20, 2026, and added to the FDA's Enforcement Report June 23, 2026, with US Nationwide distribution.
The agency stated that five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
5 products
Affected if its UDI-DI, lot code and catalog code are listed under that product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/
- UDI-DI
- 110040241
- 00889024681941
- Catalog code
- 110040241
- Lot code
- 099463
- 099464
- 099465
- 099467
Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/
- UDI-DI
- 110040476
- 00889024682047
- Catalog code
- 110040476
- Lot code
- 097492
Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/
- UDI-DI
- 110040444
- 00889024681903
- Catalog code
- 110040444
- Lot code
- 097487
Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/
- UDI-DI
- 110040240
- 00889024681965
- Catalog code
- 110040240
- Lot code
- 099457
- 099458
Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide Model/
- UDI-DI
- 110040242
- 00889024681989
- Catalog code
- 110040242
- Lot code
- 099471
- 099473
- 099474
- 099475
Recall details
- Company began the recall
- Sold in
US Nationwide distribution.
- Company
- Zimmer, Inc.Warsaw, Indiana
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99045
- Recall numbers
- Z-2527-2026 to Z-2531-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
