Quick Facts at a Glance
- Recall Date
- February 3, 2026
- Hazard Level
- HIGH
- Brand
- Exactech
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- Nationwide (50 states)
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Exactech
- Product type
- Core Instrument Kit
- Model numbers
- KIT-311X, All Lots/ UDI-DI: 10885862559166
- Sold at
- Unknown
- Where affected
- Nationwide
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
February 3, 2026
Reported by FDA DEVICE
March 18, 2026
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Impactor handle may be missing cross-pin
What You Should Do
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
About This Product
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.
Why This Is Dangerous
A missing cross-pin on the impacter handle may affect tool integrity and functionality during procedures.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
Immediate action is required to stop use. The recall affects hospital procurement and patient safety by ensuring proper instrument integrity.
Practical Guidance
How to identify if yours is affected
- Identify model KIT-311X and UDI-DI 10885862559166
- Confirm lot information against recall notices
- Review supplier communications for recall instructions
Where to find product info
UDI mark and model information are typically located on the instrument kit packaging and documentation.
What timeline to expect
Remedy details and replacement timelines will be provided by Exactech; monitor official recall notices.
If the manufacturer is unresponsive
- Contact hospital risk management
- File a recall report with the FDA if applicable
How to prevent similar issues
- Verify instrument kit integrity before use
- Establish a recall monitoring process for surgical instruments
- Ensure vendor compliance and timely updates
Documentation advice
Keep copies of all recall notices, communications with Exactech, and any disposition guidance from healthcare facilities.
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Product Details
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.
Reported Incidents
No injury counts are provided in the recall notice. The recall status is active with hazard level HIGH.
Key Facts
- Distribution across US and international markets
- Ranked HIGH hazard level
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Safety Guide
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