Z-1510-2026Class II

Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311X

Name: Z-1510-2026 Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311X
Creator: Exactech, Inc.
Published: 2026-02-03
License: https://open.fda.gov/license/

Exactech, Inc. / initiated 2026-02-03 / Open, Classified

FDA source

Exactech, Inc. began a recall of Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311X on 2026-02-03. FDA classified it as Class II and gives the reason as "Impactor handle may be missing cross-pin". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1510-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-02-03
Posted: 2026-03-09
Recalling firm: Exactech, Inc.
Product: Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311X
Product code: HWA Impactor
Reason for recall: Impactor handle may be missing cross-pin
FDA root cause: Under Investigation by firm
Action: On 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 [email protected] within 5 business days.
Quantity in commerce: 596 kits
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
Product codes and lots: All Lots/ UDI-DI: 10885862559166

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1510-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1509-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-18	2026-03-09
Z-1510-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-18	2026-03-09

Product code HWA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)