FDA Medical devices recall ·
Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis… recall
- Recall number
- Z-2529-2026
- Date
- (initiated May 20, 2026)
- Company / brand
- Zimmer, Inc.
1800 W Center St, Warsaw, IN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 429 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040242
Why was it recalled?
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
Distribution
US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2529-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.