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.
Impactor handle may be missing cross-pin
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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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.
A missing cross-pin could compromise the handle’s attachment or alignment, leading to instrument failure during use and potential patient harm.
This recall is not indicated as part of a broader industry pattern in the provided notice.
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.
Recall information and instructions are posted by the FDA at the enforce_rpt page for recall Z-1509-2026.
The notice does not specify a timeline for remedies. Healthcare facilities should follow Exactech's instructions and any FDA guidance.
Keep all recall letters, emails, and attachments. Record serial numbers, UDI-DI, lot numbers, and replacement progress with dates.
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.
No injuries or incidents have been reported.
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