CLASS II ONGOING Device recall · Reported 18 Mar 2026 · FDA Enforcement Report

Equinoxe Ergo Modular Impactor Handle recalled by Exactech

Exactech is recalling Equinoxe Ergo Modular Impactor Handle, distributed in 19 states. The recall was initiated on 3 Feb 2026 and the FDA has classified it as Class II.

Check your package

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

Quantity recalled120 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1509-2026
FDA event ID: 98376
Recalling firm: Exactech, Gainesville, FL
Classification: Class II
Status: Ongoing
Recall initiated: 3 Feb 2026
FDA classified: 9 Mar 2026
Reported: 18 Mar 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

3 Feb 2026	Recall initiated by company
9 Mar 2026	Classified by FDA	+34 days
18 Mar 2026	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Impactor handle may be missing cross-pin

Product as listed by the FDA

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

Where it was distributed

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

California Colorado Florida Georgia Illinois Kansas Kentucky Louisiana Massachusetts Maryland Minnesota Nevada New York Puerto Rico South Carolina Tennessee Texas Virginia Wisconsin

Questions about this recall

Why was it recalled?

Impactor handle may be missing cross-pin

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 98376

Reported	Class	Recall	Company	Reason	Where
18 Mar 2026	CLASS II	Equinoxe Core Instrument Kit recalled by Exactech	Exactech	Other	19 states

More recalls from Exactech

All 197

Reported	Class	Recall	Company	Reason	Where
18 Mar 2026Device	CLASS II	Equinoxe Core Instrument Kit recalled by Exactech	Exactech	Other	19 states
26 Nov 2025Device	CLASS II	Equinoxe Ergo Adjustable Angle rTSA Reamer recalled by Exactech	Exactech	Device Malfunction	SC
26 Nov 2025Device	CLASS II	Equinoxe Ergo Augments Pilot Tip Converter recalled by Exactech	Exactech	Device Malfunction	SC
26 Nov 2025Device	CLASS II	Equinoxe Ergo Adjustable Angle rTSA Reamer recalled by Exactech	Exactech	Device Malfunction	SC
24 Sep 2025Device	CLASS II	Equinoxe, Reverse Shoulder Humeral Liners recalled by Exactech	Exactech	Other	Nationwide

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