Z-0537-2013 Class II Terminated
FDA device recall Z-0537-2013 was initiated by Zimmer, Inc. on Nov 19, 2012 and is designated Class II. 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… The recall status is terminated (terminated Apr 17, 2014). Affected quantity: 23.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 26, 2012
- Initiation Date
- Nov 19, 2012
- Termination Date
- Apr 17, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 23
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.
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 .
Distribution Pattern
Worldwide distribution - USA nationwide and the countries of: Canada, Germany, Finland, Japan, Italy, San Juan, Switzerland, and UK.
Code Information
Catalog 32-8106-000-03; Lot 61644802
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0537-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026