Z-1239-2018Class II

Coonrad/Morrey Elbow Implant System humeral assembly 4IN XSML, Item Number: 32-8105-027-04 (UDI...

Name: Z-1239-2018 Coonrad/Morrey Elbow Implant System humeral assembly 4IN XSML, Item Number: 32-8105-027-04 (UDI...
Creator: Zimmer Biomet, Inc.
Published: 2018-01-24
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2018-01-24 / Terminated

FDA source

Zimmer Biomet, Inc. began a recall of Coonrad/Morrey Elbow Implant System humeral assembly 4IN XSML, Item Number: 32-8105-027-04 (UDI: (01)0088902427 4006(17)220731(10)63694912) on 2018-01-24. FDA classified it as Class II and gives the reason as "One lot of humeral stem implants do not include the humeral bushing components". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1239-2018
Classification: Class II
Status: Terminated
Initiated: 2018-01-24
Posted: 2018-03-14
Terminated: 2019-04-09
Recalling firm: Zimmer GmbH
Product: Coonrad/Morrey Elbow Implant System humeral assembly 4IN XSML, Item Number: 32-8105-027-04 (UDI: (01)0088902427 4006(17)220731(10)63694912)
Product code: JDC Prosthesis, Elbow, Constrained, Cemented
Reason for recall: One lot of humeral stem implants do not include the humeral bushing components.
FDA root cause: Under Investigation by firm
Action: 1. Immediately locate and quarantine affected product in your inventory. 2. Immediately return all affected product from your distributorship and from affected hospitals within your territory. a. Complete Inventory Return Certification Form and send to [email protected] within three (3) days. b. Request a Return Authorization Number. Mark RECALL on the outside of the returned cartons.
Quantity in commerce: 9
Distribution: Distributed in China and Taiwan.
Product codes and lots: Lot Number: 63694912

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1239-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1239-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-28

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)