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Zimmer, Inc. recalls Zimmer Trabecular Metal Total Ankle Tibial Base Component Sizes 1-6 Total ankle arthroplasty is intended to provide
Recalled December 18, 2013 · FDA recall Z-0477-2014 · Zimmer
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 · FDA Class II
Units
390 units (US) 129 units (outside of US)
Sold at
Worldwide Distribution - USA (nationwide) and Internationally to Australia, Canada, China, Finland, Germany, and Italy.
Description
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
Product
Zimmer Trabecular Metal Total Ankle Tibial Base Component 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.
Manufacturer(s)
Zimmer, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →