Z-1000-2020Class II

Coonrad/Morrey Total Elbow Humeral Assembly, Extra Small, 4-inch Length. Model No. 32-8105-027-04. UDI...

Name: Z-1000-2020 Coonrad/Morrey Total Elbow Humeral Assembly, Extra Small, 4-inch Length. Model No. 32-8105-027-04. UDI...
Creator: Zimmer Biomet, Inc.
Published: 2019-12-12
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2019-12-12 / Terminated

FDA source

Zimmer Biomet, Inc. began a recall of 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... on 2019-12-12. FDA classified it as Class II and gives the reason as "The lot contained two outer pins instead of one outer and one inner pin". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1000-2020
Classification: Class II
Status: Terminated
Initiated: 2019-12-12
Posted: 2020-02-05
Terminated: 2021-01-13
Recalling firm: Zimmer GmbH
Product: 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.
Product code: JDC Prosthesis, Elbow, Constrained, Cemented
Reason for recall: The lot contained two outer pins instead of one outer and one inner pin.
FDA root cause: Under Investigation by firm
Action: On December 12, 2019, the firm distributed Urgent Medical Device Recall letters to affected customers. The letter alerted customers that the product was potentially packaged with two outer pins and zero inner pins. Customer responsibilities: 1. Review the notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. Complete the included Certificate of Acknowledgement and send to [email protected]. This form will be returned even if you do not have affected products at your facility. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. 5. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to [email protected]
Quantity in commerce: 3
Distribution: Distributed to accounts in California and Ohio.
Product codes and lots: Lot 64481139

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1000-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1000-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05

Product code JDC

K001989Class IICoonrad/morrey Total Elbow. Model 32-8105 SeriesZimmer, Inc. / cleared 2000-07-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)