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U.S. Department of Health and Human Services

Class 2 Device Recall Equinoxe Core Instrument Kit

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 Class 2 Device Recall Equinoxe Core Instrument Kitsee related information
Date Initiated by FirmFebruary 03, 2026
Date PostedMarch 09, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1510-2026
Recall Event ID 98376
Product Classification Impactor - Product Code HWA
ProductBrand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311X
Code Information All Lots/ UDI-DI: 10885862559166
FEI Number 1038671
Recalling Firm/
Manufacturer		 Exactech, Inc.
2320 Nw 66th Ct
Gainesville FL 32653-1630
For Additional Information ContactAurelio Sahagun
+1-352-3771140
Manufacturer Reason
for Recall		Impactor handle may be missing cross-pin
FDA Determined
Cause 2		Under Investigation by firm
ActionOn February 5, 2026, Exactech issued a Urgent Medical Device Recall Notification Expansion to affected consignees. Initial notification was issued on January 23, 2026. Exactech asked consignees to take the following actions: 1. IMMEDIATELY CEASE USE AND DISTRIBUTION. Stop using or distributing any Ergo Impactor Handle (321-09-05) from the affected lots. 2. CAREFULLY REVIEW THIS NOTIFICATION. Ensure all personnel understand the issue and required actions. 3. IDENTIFY, QUARANTINE AND RETURN 4. EXTEND THIS INFORMATION. Communicate this notice to all accounts that were shipped or may have been shipped affected units. 5. Response Form. A mandatory response form is attached. Please complete and return it to recalls@advita.com within 5 business days.
Quantity in Commerce596 kits
DistributionUS: 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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