Zimmer, Inc.: Medical Device Recall in 2012 - (Recall #: Z-0537-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: November 19, 2012

Date Posted: December 26, 2012

Recall Number: Z-0537-2013

Event ID: 63641

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 .

Status: Terminated

Product Quantity: 23

Code Information:

Catalog 32-8106-000-03; Lot 61644802

Distribution Pattern:

Worldwide distribution - USA nationwide and the countries of: Canada, Germany, Finland, Japan, Italy, San Juan, Switzerland, and UK.

Voluntary or Mandated:

Voluntary: Firm initiated