Zimmer, Inc.: Shoulder Prosthesis, Reverse Configuration
Recall Summary Zimmer, Inc. is recalling the Off-Axis Comprehensive Shoulder System (Medium, Augment model 110040241) used in reverse shoulder replacement surgery. The plastic guides in this device can break during the reaming process, as reported in five complaints. The product was distributed nationwide across all U.S. states.
- Recalling firm
- Zimmer, Inc.
- Product
- Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241
- 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/0de61aff-9573-4b9b-b6cb-793b19cbc203