Zimmer Off-Axis Shoulder System Recalled Due to Plastic Guide Breakage
Zimmer recalls Off-Axis Comprehensive Shoulder System model 110040241 due to plastic guides catching during reaming, causing breakage. Five complaints reported.
Lower-risk recall
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Contact the company
What happened, in plain English
Zimmer is recalling a specific shoulder surgery device model because plastic guides can break during use, leading to potential complications. This affects patients who have received this exact model for surgery. Read more at govinfonow.com/recall/49135-zimmer-off-axis-shoulder-system-recalled-due-to-plastic-guide.
Source Summary by GovInfoNow · govinfonow.com/recall/49135-zimmer-off-axis-shoulder-system-recalled-due-to-plastic-guide · Updated August 10, 2026 · FDA enforcement record: FDA #Z-2528-2026
Cite this page
“Zimmer Off-Axis Shoulder System Recalled Due to Plastic Guide Breakage.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/49135-zimmer-off-axis-shoulder-system-recalled-due-to-plastic-guide. Based on FDA recall #Z-2528-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2528-2026%22&limit=1).
Why it’s dangerous
The plastic guides in this surgical device can catch during the reaming process, causing them to break. This breakage may lead to complications during surgery or require additional procedures.
Who’s affected
Patients who received the Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide model 110040241 during surgery are most at risk. This device is used in orthopedic procedures.
How to tell if you have this one
Check for the model number 110040241 on the device. The product was sold with specific lot codes including 099463, 099464, 099465, and 099467.
- Brand
Zimmer- Product
Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241- Category
Medical device
All 5 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
US Nationwide distribution.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2527-2026 | Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240; Lot Code: Model No. 110040240 ; UDI-DI (01)00889024681965(17)350601(10)099457 ; Lot Number 099457 Model No. 110040240 ; UDI-DI (01)00889024681965(17)350712(10)099458 ; Lot Number 099458 | 474 units |
| Z-2528-2026 | Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241; 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 | 435 units |
| Z-2529-2026 | Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040242; Lot Code: Model No. 110040242 ; UDI-DI (01)00889024681989(17)350601(10)099471 ; Lot Number 099471 Model No. 110040242 ; UDI-DI (01)00889024681989(17)350614(10)099473 ; Lot Number 099473 Model No. 110040242 ; UDI-DI (01)00889024681989(17)350804(10)099474 ; Lot Number 099474 Model No. 110040242 ; UDI-DI (01)00889024681989(17)350806(10)099475 ; Lot Number 099475 | 429 units |
| Z-2530-2026 | Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040444; Lot Code: 110040444 ; UDI-DI (01)00889024681903(17)350531(10)097487 ; Lot Number 097487 | 11 units |
| Z-2531-2026 | Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040476; Lot Code: Model No. 110040476 ; UDI-DI (01)00889024682047(17)350531(10)097492 ; Lot Number 097492 | 13 units |
What to do — step by step
Check Device Model
Look for the model number 110040241 on the device to confirm if it is recalled.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 42 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2528-2026 (May 20, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2528-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.