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FDA (Device enforcement)Recalled 2026-02-03class ii

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

Hazard

Impactor handle may be missing cross-pin

Details from the source

Reason for recall: Impactor handle may be missing cross-pin Distribution: US: 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 Quantity: 120 units 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)

UPC codes

10885862557674

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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