Conformis Recalls iTotal Hip Replacement System Due to Incorrect Components
Conformis, Inc. is recalling two iTotal Hip Replacement Systems because incorrect hip components were provided in the kits.
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 involves a high-risk medical device (hip replacement) with a defect (incorrect components) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Conformis, Inc. is recalling two units of the iTotal Hip Replacement System, Model number HAA-050-D020-020102. The recall is due to incorrect hip components being provided in the kits.
The affected products include standard hip replacement components as well as patient-specific components, specifically the femoral stem and single-use instrumentation. The units are identified by serial number 0469255. The products were distributed in California.
The recalled product
- Product
- iTotal Hip Replacement System, Model number HAA-050-D020-020102 The Conformis Hip System includes standard hip replacement components as well as the following patient specific components: femoral stem and single use instrumentation.
- Manufacturer
- Conformis, Inc.
- Hazard
- Affected units
- 2
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)
- Serial numbers 0469255
- 0469255
Distribution
Distributed in 1 state:
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