CLASS II ONGOING Device recall · Reported 27 Jan 2021 · FDA Enforcement Report

Equinoxe Humeral Stem, Primary, Press Fit recalled by Exactech

Exactech is recalling Equinoxe Humeral Stem, Primary, Press Fit, distributed nationwide in the US. The recall was initiated on 9 Nov 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog Number: 300-01-11; Packaging Lot: 49088921; UDI: 10885862079312; Serial Numbers: 6477393, 6477394, 6477395, 6477397, 6477398, 6477399, 6477400, 6477401, 6477402, 6477403, 6477404, 6477405, 6477406, and 6477407.

Quantity recalled14 devices

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-0884-2021
FDA event ID: 86760
Recalling firm: Exactech, Gainesville, FL
Classification: Class II
Status: Ongoing
Recall initiated: 9 Nov 2020
FDA classified: 21 Jan 2021
Reported: 27 Jan 2021
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

9 Nov 2020	Recall initiated by company
21 Jan 2021	Classified by FDA	+73 days
27 Jan 2021	Published in enforcement report	+6 days

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

Reason for recall

Potential for incorrect Instructions For Use (IFU) included with an Equinoxe Humeral Stem, Primary, Press Fit, 11mm package.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Equinoxe Humeral Stem, Primary, Press Fit, 11mm

Where it was distributed

Distributed within the US to KS, OH, CA. International distribution to Australia and Germany.

Nationwide California Kansas Ohio

Questions about this recall

Is Equinoxe Humeral Stem, Primary, Press Fit recalled?

Yes. Exactech recalled Equinoxe Humeral Stem, Primary, Press Fit on 9 Nov 2020. The recall is Class II and its status is Ongoing. Recall number Z-0884-2021.

Why was it recalled?

Potential for incorrect Instructions For Use (IFU) included with an Equinoxe Humeral Stem, Primary, Press Fit, 11mm package.

Which lots are affected?

Catalog Number: 300-01-11; Packaging Lot: 49088921; UDI: 10885862079312; Serial Numbers: 6477393, 6477394, 6477395, 6477397, 6477398, 6477399, 6477400, 6477401, 6477402, 6477403, 6477404, 6477405, 6477406, and 6477407.

Where was it sold?

Distributed within the US to KS, OH, CA. International distribution to Australia and Germany.

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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