PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: December 18, 2013 Initiated: November 12, 2013 #Z-0476-2014

Product Description

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.

Reason for Recall

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

Details

Recalling Firm
Zimmer, Inc.
Units Affected
265 units (US) 114 units (outside US)
Distribution
Worldwide Distribution - USA (nationwide) and Internationally to Australia, Canada, China, Finland, Germany, and Italy.
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Zimmer, Inc.. Units affected: 265 units (US) 114 units (outside US).
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 18, 2013. Severity: Moderate. Recall number: Z-0476-2014.

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