Zimmer Trabecular Metal Total Ankle Tibial Base Component Recall
Zimmer, Inc. is recalling specific sizes of the Trabecular Metal Total Ankle Tibial Base Component due to potential elevated levels of manufacturing residue.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a potential for elevated manufacturing residue, representing a risk-of-harm product where specific injury reports are not detailed in the source text.
Plain-English summary
Zimmer, Inc. is recalling the Zimmer Trabecular Metal Total Ankle Tibial Base Component, sizes 1 through 6. The recall involves 390 units distributed in the United States and 129 units distributed internationally to Australia, Canada, China, Finland, Germany, and Italy.
The recall was initiated after routine manufacturing process monitoring revealed that the Tibial Base and Talar Components from the Total Ankle system have the potential to contain elevated levels of manufacturing materials residue. The specific material identified is mass media utilized during the manufacturing process to provide a uniform surface finish on the implants.
This device is intended for cemented use in total ankle replacement surgery for patients with rheumatoid arthritis, post-traumatic arthritis, or degenerative arthritis. Patients who have received this implant should contact their healthcare provider for guidance regarding the recall.
The recalled product
- 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
- Manufacturer
- Zimmer, Inc.
- Hazard
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Zimmer, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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