Recall Z-0538-2013 ยท JDC Prosthesis, Elbow, Constrained, Cemented
Zimmer, Inc.
Coonrad/Morrey New Ulnar Revision Kit for Use with Non-Interchangeable Regular Humerals STERILE Rx, Tivanium 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.
| Date | Dec 18, 2012 (initiated Nov 19, 2012) |
| 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 . |
| 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 |
| Quantity | 17 |
| Distribution | Worldwide distribution - USA nationwide and the countries of: Canada, Germany, Finland, Japan, Italy, San Juan, Switzerland, and UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001989 | COONRAD/MORREY TOTAL ELBOW. MODEL 32-8105 SERIES Zimmer, Inc., Jul 25, 2000 |