Class II — Zimmer, Inc.
| Recalling firm | ZIMMER, INC. |
|---|---|
| Registered facility | View this company's 10 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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 . |
| 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. |
| Quantity | 23 |
| Distribution | Worldwide distribution - USA nationwide and the countries of: Canada, Germany, Finland, Japan, Italy, San Juan, Switzerland, and UK. |
| Initiated | 2012-11-19 |
| Classified | 2012-12-17 |
| Terminated | 2014-04-17 |
| Recall number | Z-0537-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Zimmer, Inc. (Z-0537-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/63641/
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