Off-Axis Comprehensive Shoulder System Small recall
Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240
Why was Off-Axis Comprehensive Shoulder System Small recalled?
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240
- Recalling firm
- Zimmer, Inc.
- Quantity
- 474 units
- Distribution
- US Nationwide distribution.
- Recall date
- July 1, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)