Zimmer Coonrad/Morrey Total Elbow, Interchangeable Ulnar Assembly, plasma sprayed, extra small, right, 3 inch length, st
FDA device recall Z-1056-2009 · posted 2009-04-02 · Terminated
Recall details
- Recalling firm
- Zimmer Inc.
- 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.
- 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.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- JDC
- Quantity affected
- 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
- Date initiated
- 2009-01-30
- Date posted
- 2009-04-02
- Date terminated
- 2009-12-22
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COONRAD/MORREY TOTAL ELBOW, MODEL 8105 SERIES (K053189) | Zimmer, Inc. | 2005-12-09 |