Zimmer Total Ankle Components Recalled for Manufacturing Residue
Zimmer, Inc. is recalling specific Total Ankle Talar Components due to potential elevated levels of manufacturing residue on the implants.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 is classified as FDA Class II. The hazard involves potential contamination of an implanted medical device with manufacturing residue, which poses a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Zimmer, Inc. is recalling specific units of the Zimmer Trabecular Metal Total Ankle Talar Component, Right Sizes 1-6. The recall involves 265 units distributed in the United States and 114 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.
Patients who have had these specific implants placed should contact their healthcare provider for guidance. The source text does not specify a consumer action for non-patients, as these are surgical implants.
The recalled product
- Product
- 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…
- Manufacturer
- Zimmer, Inc.
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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