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.
Impactor handle may be missing cross-pin
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Exactech, Inc. or your healthcare provider for instructions. Notification method: Letter
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The Equinoxe Core Instrument Kit is used in orthopedic procedures and includes surgical instruments. Hospitals and clinics typically purchase these kits for use in operating rooms.
A missing cross-pin on the impacter handle may affect tool integrity and functionality during procedures.
This recall is not described as part of a broader industry pattern in the provided data.
Immediate action is required to stop use. The recall affects hospital procurement and patient safety by ensuring proper instrument integrity.
UDI mark and model information are typically located on the instrument kit packaging and documentation.
Remedy details and replacement timelines will be provided by Exactech; monitor official recall notices.
Keep copies of all recall notices, communications with Exactech, and any disposition guidance from healthcare facilities.
Product: Equinoxe Core Instrument Kit. Model/UDI-DI: KIT-311X. Quantity: 596 kits. Distribution: US and international markets including US states and CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MN, NV, NY, OH, OK, PR, SC, TN, TX, VA, WI and international: Australia, France, Germany, Italy, Japan, Korea, Spain, Switzerland, United Kingdom, United Arab Emirates, Slovenia.
No injury counts are provided in the recall notice. The recall status is active with hazard level HIGH.
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