CLASS II ONGOING Device recall · Reported 1 Jul 2026 · FDA Enforcement Report
Off-Axis Comprehensive Shoulder System, Medium, Augment recalled
Zimmer is recalling Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide, distributed nationwide in the US. The recall was initiated on 20 May 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2528-2026
- FDA event ID
- 99045
- Recalling firm
- Zimmer, Warsaw, IN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 20 May 2026
- FDA classified
- 23 Jun 2026
- Reported
- 1 Jul 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Foreign Material
- Device type
- Other Medical Devices
Timeline
| 20 May 2026 | Recall initiated by company | |
| 23 Jun 2026 | Classified by FDA | +34 days |
| 1 Jul 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241
Where it was distributed
US Nationwide distribution.
Questions about this recall
Is Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide recalled?
Yes. Zimmer recalled Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide on 20 May 2026. The recall is Class II and its status is Ongoing. Recall number Z-2528-2026.
Why was it recalled?
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Which lots are affected?
Lot Code: Model No. 110040241 ; UDI-DI (01)00889024681941(17)350602(10)099463 ; Lot Number 099463 Model No. 110040241 ; UDI-DI (01)00889024681941(17)350531(10)099464 ; Lot Number 099464 Model No. 110040241 ; UDI-DI (01)00889024681941(17)350812(10)099465 ; Lot Number 099465 Model No. 110040241 ; UDI-DI (01)00889024681941(17)350707(10)099467 ; Lot Number 099467
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Zimmer
All 539| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Off-Axis Comprehensive Shoulder System, Large, Augment recalled | Zimmer | Foreign Material | Nationwide |
| Device | CLASS II | Off-Axis Comprehensive Shoulder System Small, Augment recalled by Zimmer | Zimmer | Foreign Material | Nationwide |
| Device | CLASS II | Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide recalled | Zimmer | Foreign Material | Nationwide |
| Device | CLASS II | Persona Revision¿ Trabecular Metal¿ Femoral Distal Augment recalled | Zimmer | Foreign Material | IN |
| Device | CLASS II | Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide recalled | Zimmer | Foreign Material | Nationwide |
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