Zimmer, Inc.: Shoulder Prosthesis, Reverse Configuration
Recall Summary Zimmer, Inc. is recalling the Off-Axis Comprehensive Shoulder System Small Augment Reamer Guide (Model 110040240), a plastic surgical guide used during shoulder replacement procedures. The plastic guides can break during the reaming process when they catch on bone, based on five reported incidents. The product was distributed nationwide across all U.S. states and the District of Columbia.
- Recalling firm
- Zimmer, Inc.
- Product
- Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240
- 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/f211a8a3-930a-4fac-9952-ea14bebb10ae