Conformis iTotal Hip Replacement System Reamed with Incorrect Interference Fit
Conformis, Inc. is recalling one iTotal Hip Replacement System because the reamer instruments used had a -1mm interference fit instead of the expected -2mm.
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 a structural deviation in a medical device (incorrect interference fit) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Conformis, Inc. is recalling one unit of the iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101. The specific unit affected has Serial Number 0424647. The product was distributed to Tennessee.
The recall was initiated because the stage 1 and 2 reamer instruments used to prepare fixation for the cup in the acetabulum had a -1mm interference fit with the acetabulum bone. The expected interference fit for these instruments is -2mm.
This is a Class II recall. The source text does not report any illnesses or injuries associated with this specific defect. Patients who have received this specific hip replacement system should contact their healthcare provider for further evaluation.
The recalled product
- Product
- iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101
- 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 0424647
Distribution
Distributed in 1 state:
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