Recall Z-1054-2009
Zimmer Inc. · initiated January 30, 2009
Product
Zimmer Coonrad/Morrey Total Elbow, Interchangeable Humeral Assembly, extra small, 6 inch length, sterile, Zimmer Inc, Warsaw, IN; REF 32-8105-027-06. The device is utilized for a total elbow arthroplasty surgical procedure.
Codes / lots: All lots.
Reason for recall
The surgical technique is inadequate for extra-small sized implants, resulting in the possibility of the provisional becoming stuck in the bone.
FDA-determined cause: Labeling design
Action taken
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.
Details
- Recall number
- Z-1054-2009
- Initiated
- January 30, 2009
- Posted by FDA
- April 2, 2009
- Terminated
- December 22, 2009
- Product code
- JDC – Prosthesis, Elbow, Constrained, Cemented
- 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, Switzerland, Taiwan, Thailand, Turkey and Venezuela.
- Recalling firm
- Zimmer Inc., Warsaw, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1053-2009 | Zimmer Coonrad/Morrey Total Elbow, Interchangeable Humeral Assembly, extra small, 4 inch…The surgical technique is inadequate for extra-small sized implants, resulting in the possibility of the… | 01/30/2009Terminated |
| Z-1055-2009 | Zimmer Coonrad/Morrey Total Elbow, Interchangeable Ulnar Assembly, plasma sprayed, extra…The surgical technique is inadequate for extra-small sized implants, resulting in the possibility of the… | 01/30/2009Terminated |
| Z-1056-2009 | Zimmer Coonrad/Morrey Total Elbow, Interchangeable Ulnar Assembly, plasma sprayed, extra…The surgical technique is inadequate for extra-small sized implants, resulting in the possibility of the… | 01/30/2009Terminated |
| Z-1057-2009 | Zimmer Coonrad/Morrey Total Elbow, Interchangeable Ulnar Assembly, plasma sprayed, extra…The surgical technique is inadequate for extra-small sized implants, resulting in the possibility of the… | 01/30/2009Terminated |
| Z-1058-2009 | Zimmer Coonrad/Morrey Total Elbow, Interchangeable Ulnar Assembly, plasma sprayed, extra…The surgical technique is inadequate for extra-small sized implants, resulting in the possibility of the… | 01/30/2009Terminated |