Conformis Recalls iTotal CR Knee Replacement System Due to Fit Issues
Conformis, Inc. is recalling the iTotal CR Knee Replacement System because the polyethylene inserts did not securely fit into the cobalt chrome tray implant.
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 and involves a structural defect in a medical implant where components did not fit securely. Per the rubric, risk-of-harm products where injury has not yet been reported are rated High (3).
Plain-English summary
Conformis, Inc. is recalling the iTotal CR Knee Replacement System, Model Number TCR-111-1111-010102. The recall is due to a defect where the medial and lateral polyethylene inserts did not securely fit into the cobalt chrome tray implant.
The affected unit has Serial Number 0450585. The product was distributed nationwide in the United States, specifically within the state of Georgia. The iTotal CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability.
No specific instructions for consumers are provided in the source text. The agency classification for this recall is Class II.
The recalled product
- Product
- iTotal CR Knee Replacement System Model Number: TCR-111-1111-010102 - Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a…
- Manufacturer
- Conformis, Inc.
- Affected units
- 1
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 (1)
- Serial Number: 0450585
Distribution
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