FDA-Device2013-12-18Class II
Zimmer Trabecular Metal Total Ankle Talar Component Right Sizes 1-6 Total ankle arthroplasty is intended to provide a patient with limited mobility by restoring alignment, reducing pain and preserving the flexion/extension movement within the ankle joint.The Zimmer Trabecular Metal Total Ankle is indicated as a total ankle replacement in primary or revision surgery for patients with: " Rheumatoid arthritis. " Post-traumatic arthritis. " Degenerative arthritis. This device is intended for ceme
Zimmer, Inc.
Hazard
As part of routine manufacturing process monitoring by Zimmer, it was discovered that the Tibial Base and Talar Components from the Total Ankle system have the potential of containing elevated levels of manufacturing materials residue on the implants. The specific material was found to be mass media utilized during the manufacturing process to provide the uniform surface finish. This mass media
Sold states
Worldwide Distribution - USA (nationwide) and Internationally to Australia, Canada, China, Finland, Germany, and Italy.
Affected count
265 units (US) 114 units (outside US)
Manufactured in
345 E Main St, Warsaw, IN, United States
Products
Zimmer Trabecular Metal Total Ankle Talar Component Right Sizes 1-6 Total ankle arthroplasty is intended to provide a patient with limited mobility by restoring alignment, reducing pain and preserving the flexion/extension movement within the ankle joint.The Zimmer Trabecular Metal Total Ankle is indicated as a total ankle replacement in primary or revision surgery for patients with: " Rheumatoid arthritis. " Post-traumatic arthritis. " Degenerative arthritis. This device is intended for cemented use only.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0476-2014Don't want to check this manually?
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