Z-0537-2013Class II

Coonmad/morrey Total Elbow Elbow Component Replacement Set Bushings & Pins for Use W/size Regular Elbow Elbow...

Name: Z-0537-2013 Coonmad/morrey Total Elbow Elbow Component Replacement Set Bushings & Pins for Use W/size Regular Elbow Elbow...
Creator: Zimmer, Inc.
Published: 2012-11-19
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2012-11-19 / Terminated

FDA source

Zimmer, Inc. began a recall of COONMAD/MORREY TOTAL ELBOW ELBOW COMPONENT REPLACEMENT SET BUSHINGS & PINS FOR USE W/SIZE REGULAR ELBOW ELBOW COMP REPLACEMENT-REG SET STERILE PROD CLASS: 4100... on 2012-11-19. FDA classified it as Class II and gives the reason as "Zimmer is initiating a lot specific recall because affected lots could include an extra Small Inner Pin instead of the required Regular Inner Pin in the Coonrad/Morrey Elbow Replacement Set and the New Ulnar Revision Kit". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0537-2013
Classification: Class II
Status: Terminated
Initiated: 2012-11-19
Posted: 2012-12-18
Terminated: 2014-04-17
Recalling firm: Zimmer GmbH
Product: COONMAD/MORREY TOTAL ELBOW ELBOW COMPONENT REPLACEMENT SET BUSHINGS & PINS FOR USE W/SIZE REGULAR ELBOW ELBOW COMP REPLACEMENT-REG SET STERILE PROD CLASS: 4100 OPERATION:9000 QTY/PKG:1 Product Usage: The ulnar and humeral components are connected by placing the hollow, outer axis pin across the two components and securing It with the solid Internal axis pin. The Inner and outer pin connection Is articulation point of the placement elbow.
Product code: JDC Prosthesis, Elbow, Constrained, Cemented
Reason for recall: Zimmer is initiating a lot specific recall because affected lots could include an extra Small Inner Pin instead of the required Regular Inner Pin in the Coonrad/Morrey Elbow Replacement Set and the New Ulnar Revision Kit .
FDA root cause: Process change control
Action: Zimmer sent "URGENT MEDICAL DEVICE RECALL" letter dated November 19, 2012 to Distributors, Risk Managers/ Implanting Surgeons, and direct accounts. The notice describes the product, problem, risks and actions to be taken. Consignees were instructed to immediately locate, quarantine and return affected product with the completed Inventory Return Certification form to Zimmer Product Service Department, 1777 West center St. Warsaw, IN 46580 (US accounts) or Zimmer International Logistics GmbH, ATTN: Fao Tanja Herold (Recall Warsaw), Max-Immelmann-Allee 12 79427 Eschbach Germany for international accounts. If an implant is removed from customer inventory, they were directed to provide a copy of the Risk Manager letter upon retrieval of that implant(s) to ensure all facilities are aware of the removal. Surgeons are asked to consider risk information in the letter should a patient present with unexplained symtoms. Hospitals that received direct shipments from the Warsaw Distribution Center will be sent a copy of the Risk Manager letter directly. Questions and concerns along with information on any implanted product is to be addressed to [email protected] using the provided spreadsheet or contact Zimmer at 1-800-447-5633.
Quantity in commerce: 23
Distribution: Worldwide distribution - USA nationwide and the countries of: Canada, Germany, Finland, Japan, Italy, San Juan, Switzerland, and UK.
Product codes and lots: Catalog 32-8106-000-03; Lot 61644802

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0537-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0537-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-17
Z-0538-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-17

Product code JDC

K973357Class IICoonrad/morrey Total Elbow, New Hinge PinZimmer, Inc. / cleared 1998-03-02

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)