Integra LifeSciences Recalls Cadence Tibial Tray Implant Due to Labeling Error
Integra LifeSciences is recalling 12 units of the Cadence Size 5 Left Tibial Tray Implant because the outer package label incorrectly identifies the material as Cobalt Chromium instead of Titanium.
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 2/5 (Moderate).
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 and involves a labeling error regarding material composition. Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries or illnesses are classified as Moderate.
Plain-English summary
Integra LifeSciences Corp. is recalling 12 units of the Cadence Size 5 Left Tibial Tray Implant, Catalog Number 10207205, Lot Number QJ0248. This medical device is designed to treat ankle arthritis by replacing the ankle joint with a prosthesis to reduce pain and restore alignment.
The recall was initiated following an internal review of the Cadence System labeling. The review determined that the outer package label for the specific implant size incorrectly reflects the material composition. The label states the material is Cobalt Chromium, whereas the actual material is Titanium.
The affected units were distributed in North Carolina and Pennsylvania. No specific instructions for consumers are provided in the source text, but the recall is limited to the specific catalog and lot numbers identified.
The recalled product
- Product
- Cadence Size 5 Left Tibial Tray Implant, designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring alignment, and allowing for movement at the replaced joint. Catalog Number: 10207205; Lot Number #QJ0248
- Manufacturer
- Integra LifeSciences Corp.
- Hazard
- Affected units
- 12
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Cat No. 10207205
- Lot: QJ0248
Distribution
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