iTotal Identity Knee Replacement System—incorrect tibial base plate packaged
Conformis is recalling specific units of the iTotal Identity Posterior Stabilised Knee Replacement System due to incorrect tibial base plate implants being packaged in surgical 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: This is a Class II medical device recall with no reported injuries or illnesses documented in the source. The hazard is concrete—incorrect implant packaging that could lead to wrong component use—but lacks evidence of actual harm, placing it at Score 3 per the rubric.
Plain-English summary
The iTotal Identity Posterior Stabilised (PS) Knee Replacement System, manufactured by Conformis, is being recalled due to an incorrect tibial base plate implant being packaged in the surgical kit. At least one unit with serial number 0496242 is affected.
This packaging error means the wrong surgical component could be used during knee replacement surgery if not detected during kit preparation. Healthcare facilities receiving this kit should verify all component contents match the intended surgery before proceeding with implantation.
The recalled product
- Product
- iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101
- 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: 0496242 UDI: M572TPS3011113011
Distribution
Distributed in 1 state:
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