CLASS II Device recall · Reported 7 Feb 2018 · FDA Enforcement Report

Equinoxe Cage, Glenoid, Alpha, Small recalled by Exactech

Exactech is recalling Equinoxe Cage, Glenoid, Alpha, Small, distributed in 14 states. The recall was initiated on 31 Aug 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog #: 314-13-03 Serial Range: 5013050 - 5013079

Quantity recalled30

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-0414-2018
FDA event ID: 78903
Recalling firm: Exactech, Gainesville, FL
Classification: Class II
Status: Terminated
Recall initiated: 31 Aug 2017
FDA classified: 26 Jan 2018
Reported: 7 Feb 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Hip & Knee Implants

Timeline

31 Aug 2017	Recall initiated by company
26 Jan 2018	Classified by FDA	+148 days
7 Feb 2018	Published in enforcement report	+12 days

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

Reason for recall

Potentially mislabeled.

Product as listed by the FDA

Equinoxe Cage, Glenoid, Alpha, Small Product Usage: The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemi- arthroplasty is determined by the surgeon to be the preferred method of treatment.

Where it was distributed

Worldwide distribution in the states of OH, WI, AZ, GA, VA, CA, OK, MN, TN, ME, CO, SC, FL, AL, and Puerto Rico and country of Switzerland

Alabama Arizona California Colorado Florida Georgia Maine Minnesota Oklahoma Puerto Rico South Carolina Tennessee Virginia Wisconsin

Questions about this recall

Is Equinoxe Cage, Glenoid, Alpha, Small recalled?

Yes. Exactech recalled Equinoxe Cage, Glenoid, Alpha, Small on 31 Aug 2017. The recall is Class II and its status is Terminated. Recall number Z-0414-2018.

Why was it recalled?

Potentially mislabeled.

Which lots are affected?

Catalog #: 314-13-03 Serial Range: 5013050 - 5013079

Where was it sold?

Worldwide distribution in the states of OH, WI, AZ, GA, VA, CA, OK, MN, TN, ME, CO, SC, FL, AL, and Puerto Rico and country of Switzerland

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

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26 Nov 2025Device	CLASS II	Equinoxe Ergo Adjustable Angle rTSA Reamer recalled by Exactech	Exactech	Device Malfunction	SC

Other Hip & Knee Implants recalls

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26 Aug 2026Device	CLASS II	Veritas Standard Reverse Total Shoulder Veritas Standard recalled	restor3d	Device Malfunction	Nationwide
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12 Aug 2026Device	CLASS II	U2 Total Knee System Femoral offset bushing recalled	United Orthopedic	Device Malfunction	Nationwide