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.
FDA Recall Z-1056-2009 · Posted 2009-04-02
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Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeJDC
Date Initiated2009-01-30
Date Terminated2009-12-22
Product Quantity14,613 of all products
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.
Firm 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.
Root Cause
Labeling design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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