Zimmer, Inc.: Shoulder Prosthesis, Reverse Configuration
Zimmer, Inc. is recalling a specific shoulder prosthesis component (Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model 110040444) distributed nationwide. The plastic guides on this device can break during the reaming procedure because they catch during use, according to five reported complaints. The recall affects the product across all U.S. states and the District of Columbia.
- Recalling firm
- Zimmer, Inc.
- Product
- Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040444
- 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/8e84aa44-d4e9-498e-bda0-141ebd77e329