Integra Cadence Total Ankle System Recalled Due to Tibial Fractures
Integra LifeSciences Corp. is recalling 944 units of the Cadence Total Ankle System because posterior tibial fractures have been reported.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves reported fractures, which constitutes significant injury reports under the severity rubric.
Plain-English summary
Integra LifeSciences Corp. is recalling 944 units of the Integra Cadence Total Ankle System. The recall is being conducted because posterior tibial fractures have been reported in association with the device.
The affected products are distributed nationwide and include specific model numbers and lot numbers for Cadence Tibial Trays in various sizes for both right and left ankles. The recall covers specific lots identified in the agency's documentation.
Consumers and healthcare providers should check their inventory or patient records for the specific model and lot numbers listed in the official recall notice. If the device is found, it should be removed from use and the manufacturer contacted for further instructions.
The recalled product
- Product
- Integra Cadence Total Ankle System
- Manufacturer
- Integra LifeSciences Corp.
- Hazard
- Affected units
- 944
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 (20)
- Model Number
- Item Description
- and Lot Number: 10207101
- Cadence Tibial Tray
- Size 1
- Right Lots: QJ0231
- QJ0231-G
- QJ0467
- QJ0467-G
- 10207102 Cadence Tibial Tray
- Size 2
- Right Lots: QJ0227
- QJ0227-G
- QJ0233
- QJ0469
- QJ0500
- QJ0500-G
- 10207103 Cadence Tibial Tray
- Size 3
- Right Lots: QJ0235
Distribution
Distributed nationwide across the United States.
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