Exactech Recalls

4 recalls found for Exactech. Check if any of your products are affected.

Health & Personal Care
HIGH
FDA DEVICE

Exactech Equinoxe Ergo 321-09-05 Impactor Handle Recall (120 Units, 2026)

Exactech recalled 120 Equinoxe Ergo Modular Impactor Handles after identifying a missing cross-pin. The defect could compromise instrument integrity during surgical use. Hospitals and surgeons should stop using the devices immediately and follow Exactech's recall instructions.

Exactech
Impactor handle
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Health & Personal Care
HIGH
FDA DEVICE

Exactech Equinoxe Core Instrument Kit KIT-311X Recalled for Missing Cross-Pin

Exactech recalls 596 Equinoxe Core Instrument Kit units due to a missing cross-pin on the impacter handle. The alert, categorized as a Class II recall, was issued Feb 3, 2026 and remains active. Affected kits were distributed across the United States and in multiple international markets. Stop using the device and follow manufacturer instructions for recall remedies.

Exactech
Impactor handle
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Health & Personal Care
HIGH
FDA DEVICE

Exactech Equinoxe 61,334 Reverse Shoulder Humeral Liners Recalled Worldwide (2025)

Exactech recalled 61,334 Equinoxe reverse shoulder humeral liners sold worldwide after finding the articular surface position outside labeling dimensions. The recall covers REF 320-38-00, REF 320-38-03, REF 320-42-00, and REF 320-42-03. Healthcare providers and patients should stop using the devices immediately and follow recall instructions distributed by email.

Exactech
Reverse Shoulder
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Health & Personal Care
HIGH
FDA DEVICE

Exactech Equinoxe Recalled 11,542 HumeraL Liners Worldwide Over Dimension Mismatch (2025)

Exactech recalled 11,542 Equinoxe reverse shoulder humeral liners worldwide after finding the articular surface position outside labeling specifications. The recall covers several REF numbers and UDIs and is active as of 2025. Healthcare providers were advised to stop using affected liners and follow manufacturer instructions.

Exactech
Reverse Shoulder
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