Recall Z-1056-2009 ยท JDC Prosthesis, Elbow, Constrained, Cemented
Zimmer Inc.
Zimmer Coonrad/Morrey Total Elbow, Interchangeable Ulnar Assembly, plasma sprayed, extra small, right, 3 inch length, sterile, Zimmer, Warsaw, IN; REF 32-8105-043-02. The device is utilized for a total elbow arthroplasty surgical procedure.
| Date | Apr 2, 2009 (initiated Jan 30, 2009) |
| Status | Terminated |
| Reason | The surgical technique is inadequate for extra-small sized implants, resulting in the possibility of the provisional becoming stuck in the bone. |
| Root cause | Labeling design |
| Action | Consignees were notified by "Urgent Device Correction" letter dated January 30, 2009 and provided revised surgical techniques for these extra-small implants. Direct questions about this recall to Zimmer, Inc. at 574-267-6131. |
| Quantity | 14,613 of all products |
| Distribution | Worldwide Distribution, including USA, Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Czech Republic, Denmark, England, Finland, France, Germany, Hong Kong, Hungary, India, Italy, Japan, Jordan, Latin America, Netherlands, Russia, Singapore, South Africa, South Korea, Spain, Switzerla |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053189 | COONRAD/MORREY TOTAL ELBOW, MODEL 8105 SERIES Zimmer, Inc., Dec 9, 2005 |