HIGH
FDA DEVICE
Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05
Impactor handle may be missing cross-pin
Exactech
Impactor handle
4 recalls found for Exactech. Check if any of your products are affected.
Impactor handle may be missing cross-pin
Impactor handle may be missing cross-pin
Exactech recalled 61,334 units of Reverse Shoulder Humeral Liners on August 15, 2025. The liners do not meet specified dimensional standards, posing a risk to patients. Healthcare providers and patients must stop using the devices immediately.
Exactech recalled 11,542 reverse shoulder humeral liners on August 15, 2025. The devices have an articular surface position outside of the specified dimensions. This recall affects units distributed worldwide, including several U.S. states.