CLASS II Device recall · Reported 12 Feb 2020 · FDA Enforcement Report

Coonrad/Morrey Total Elbow Humeral Assembly, Extra Small Length recalled

Zimmer Biomet is recalling Coonrad/Morrey Total Elbow Humeral Assembly, Extra Small Length, distributed in California, Ohio. The recall was initiated on 12 Dec 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 64481139

Quantity recalled3

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-1000-2020
FDA event ID: 84636
Recalling firm: Zimmer Biomet, Warsaw, IN
Classification: Class II
Status: Terminated
Recall initiated: 12 Dec 2019
FDA classified: 5 Feb 2020
Reported: 12 Feb 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Device type: Other Medical Devices

Timeline

12 Dec 2019	Recall initiated by company
5 Feb 2020	Classified by FDA	+55 days
12 Feb 2020	Published in enforcement report	+7 days

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

Reason for recall

The lot contained two outer pins instead of one outer and one inner pin.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

Coonrad/Morrey Total Elbow Humeral Assembly, Extra Small, 4-inch Length. Model No. 32-8105-027-04. UDI (01)00889024274006 (17)241031(10)64481139 The device is a Humeral component; elbow joint metal/polymer constrained cemented prosthesis.

Where it was distributed

Distributed to accounts in California and Ohio.

California Ohio

Questions about this recall

Why was it recalled?

The lot contained two outer pins instead of one outer and one inner pin.

Which lots are affected?

Lot 64481139

Where was it sold?

Distributed to accounts in California and Ohio.

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.

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