Quick Facts at a Glance
- Recall Date
- February 3, 2026
- Hazard Level
- HIGH
- Brand
- Exactech
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- 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
- Modular Surgical Impactor Handle
- Model numbers
- 321-09-05
- Sold at
- Multiple Retailers
- 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 Ergo Modular Impactor Handle is a surgical instrument used in orthopedic procedures. It is part of a modular system intended for precise impact delivery during operations.
Why This Is Dangerous
A missing cross-pin could compromise the handle’s attachment or alignment, leading to instrument failure during use and potential patient harm.
Industry Context
This recall is not indicated as part of a broader industry pattern in the provided notice.
Real-World Impact
The recall creates potential delays in surgical procedures and may require instrument replacement or reprocessing. Hospitals should halt use and implement recall instructions to protect patient safety.
Practical Guidance
How to identify if yours is affected
- Identify Part Number 321-09-05 on the device label.
- Verify UDI-DI 10885862557674 in the recall documentation.
- Consult Attachment 1 for product details.
Where to find product info
Recall information and instructions are posted by the FDA at the enforce_rpt page for recall Z-1509-2026.
What timeline to expect
The notice does not specify a timeline for remedies. Healthcare facilities should follow Exactech's instructions and any FDA guidance.
If the manufacturer is unresponsive
- Document all communications with the manufacturer.
- Escalate to hospital risk management or regulatory authorities if the manufacturer is unresponsive.
How to prevent similar issues
- Verify recall notices in facility inventory systems.
- Implement a process to track device recalls for surgical instruments.
- Check for cross-pin integrity during pre-use checks of modular handles.
Documentation advice
Keep all recall letters, emails, and attachments. Record serial numbers, UDI-DI, lot numbers, and replacement progress with dates.
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Product Details
Model/Catalog Number: 321-09-05. Quantity: 120 units. Distribution: United States and international markets including 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; OUS: Australia, France, Germany, Italy, Japan, Korea, Spain, Switzerland, United Kingdom, United Arab Emirates, Slovenia. Recall Date: 2026-02-03. Manufacturer/Brand: Exactech (Equinoxe Ergo). Sold by: Not specified in notice. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Cross-pin missing risk
- US and international distribution
- Active recall as of 2026-02-03
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Safety Guide
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