HIGH

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.

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

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

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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

  1. Identify Part Number 321-09-05 on the device label.
  2. Verify UDI-DI 10885862557674 in the recall documentation.
  3. 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.

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

  • 120 units recalled
  • Model 321-09-05
  • UDI-DI 10885862557674
  • Cross-pin missing risk
  • US and international distribution
  • Active recall as of 2026-02-03
View Original Recall on FDA - Medical Devices

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Safety Guide

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
LACERATIONOTHER

Product Classification

Product TypeModular Surgical Impactor Handle
Sold At
Multiple Retailers

Product Details

Model Numbers
321-09-05
Affected States
Nationwide
Report Date
March 18, 2026
Recall Status
ACTIVE

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