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Recall Observatory FDA recall evidence

Device product

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

Z-1509-2026

February 03, 2026

Class II

Product summary

Firm
Exactech, Inc.
Event
Event 98376
Status
Ongoing
Classification
Class II
Quantity
120 units
Official record key
device-enforcement:Z-1509-2026

Official wording

Reason: Impactor handle may be missing cross-pin

Code information: Lot Code: Part Number: 321-09-05 UDI-DI: 10885862557674 Lot Number: All (Please refer to Attachment 1 - Product Information Spreadsheet for details)

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Impactor handle may be missing cross-pin