Zimmer Trabecular Metal Total Ankle Talar Component Recall for Residue
Zimmer, Inc. is recalling specific Total Ankle Talar Components because routine monitoring found potential elevated levels of manufacturing residue on the implants.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves potential manufacturing residue, but the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer, Inc. is recalling the Zimmer Trabecular Metal Total Ankle Talar Component, Left Sizes 1-6. The recall involves 269 units in the United States and 110 units distributed outside the US. The affected devices were distributed nationwide in the US and internationally to Australia, Canada, China, Finland, Germany, and Italy.
The recall was initiated after routine manufacturing process monitoring by Zimmer discovered that the Tibial Base and Talar Components from the Total Ankle system have the potential of containing elevated levels of manufacturing materials residue. The specific material identified was mass media utilized during the manufacturing process to provide a uniform surface finish.
Patients who have had this specific implant placed should contact their healthcare provider for evaluation. The device is intended for cemented use in total ankle replacement surgery for patients with rheumatoid arthritis, post-traumatic arthritis, or degenerative arthritis.
The recalled product
- Product
- Zimmer Trabecular Metal Total Ankle Talar Component Left 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 M
- 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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