Zimmer, Inc.: Shoulder Prosthesis, Reverse Configuration
Summary Zimmer, Inc. is recalling a large shoulder prosthesis reamer guide (model 110040242) used in reverse shoulder replacement surgery because plastic guides have broken during use in five reported cases. The affected product was distributed nationwide across all U.S. states. This is a Class II recall, which indicates a potential health risk but not an immediate life-threatening situation.
- Recalling firm
- Zimmer, Inc.
- Product
- Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040242
- Reason
- Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-05-20
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/11af5e19-b10d-4443-965b-a0f979bd329b