CLASS II Device recall · Reported 13 Nov 2019 · FDA Enforcement Report

Sidus Stem-Free Shoulder Humeral Head recalled by Zimmer Biomet

Zimmer Biomet is recalling Sidus Stem-Free Shoulder Humeral Head, distributed nationwide in the US. The recall was initiated on 10 Oct 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll product manufactured prior to January 2014.

Quantity recalled5,459,583 total 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-0300-2020
FDA event ID: 83962
Recalling firm: Zimmer Biomet, Warsaw, IN
Classification: Class II
Status: Terminated
Recall initiated: 10 Oct 2019
FDA classified: 7 Nov 2019
Reported: 13 Nov 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

10 Oct 2019	Recall initiated by company
7 Nov 2019	Classified by FDA	+28 days
13 Nov 2019	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

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

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

Sidus Stem-Free Shoulder Humeral Head, Item Nos. 0104555380 0104555400 0104555420 0104555440 0104555460 0104555480 0104555485 0104555500 0104555505 0104555520 0104555525

Where it was distributed

Distributed nationwide.

Nationwide

Questions about this recall

Is Sidus Stem-Free Shoulder Humeral Head recalled?

Yes. Zimmer Biomet recalled Sidus Stem-Free Shoulder Humeral Head on 10 Oct 2019. The recall is Class II and its status is Terminated. Recall number Z-0300-2020.

Why was it recalled?

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Which lots are affected?

All product manufactured prior to January 2014.

Where was it sold?

Distributed nationwide.

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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