Conformis iTotal CR Knee Replacement System Recalled for Labeling Addendum
Conformis Inc is recalling 1,427 iTotal CR Knee Replacement Systems to add a labeling addendum with detailed surgical instructions for poly insertion.
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 addendum for surgical instructions. Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries fall under Moderate severity.
Plain-English summary
Conformis Inc is recalling 1,427 units of the iTotal CR-Cruciate Retaining Knee Replacement System. The affected model numbers are M57250600010 (Left Knee) and M57250600020 (Right Knee). The recall covers all serial numbers and includes units distributed worldwide, specifically in the United States and Germany.
The recall was initiated to add a labeling addendum to the iTotal CR Surgical Technique. This addendum provides detailed instructions for the Total CR Poly Insertion Technique. The product is intended for use as a total knee replacement in patients with knee joint pain and disability that cannot be addressed by partial prostheses.
This is a Class II recall. No specific injuries or illnesses are reported in the source text. Healthcare providers and patients should consult the updated surgical technique documentation for proper insertion instructions.
The recalled product
- Product
- Conformis iTotal CR-Cruciate Retaining Knee Replacement System Model Numbers: M57250600010 iTotal CR, Left Knee M57250600020 iTotal CR, Right Knee Product Usage : Usage: The iTotal CR Knee Replacement System (KRS) is intended for use as a total knee replacement in…
- Manufacturer
- Conformis Inc
- Hazard
- Affected units
- 1,427
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)
- All serial numbers
Distribution
Distributed nationwide across the United States.
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