medical MODERATE Updated 2026-03-18

Exactech, Inc. recalls Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impact

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Recalled Product

Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05

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Hazard / Issue

Impactor handle may be missing cross-pin

Issued by

FDA

Affected States: CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MN, NV, NY, OH, OK, SC, TN, TX, VA, WI
Lot/Code Info: Lot Code: Part Number: 321-09-05 UDI-DI: 10885862557674 Lot Number: All (Please refer to Attachment 1 - Product Information Spreadsheet for details)

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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