Exactech, Inc. is recalling 716 Ergo Modular Impactor Handles and Equinoxe Core Instrument Kits because the impactor handle may be missing a critical cross-pin. The recall affects 120 individual units of the Ergo Modular Impactor Handle and 596 Equinoxe Core Instrument Kits distributed globally. Patients and healthcare providers should be aware that a missing pin could compromise the mechanical integrity of the surgical instrument during use. Exactech initiated this recall via letter to customers on February 3, 2026.
A missing cross-pin in the impactor handle can cause the device to fail or break during surgical procedures. This poses a risk of surgical delay or injury to the patient if the instrument does not function as intended while being used to implant medical devices.
Please refer to Attachment 1 - Product Information Spreadsheet for details regarding all lot numbers.
Includes the affected impactor handle within the kit.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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