FDA-Device2020-09-02Class II
Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat: TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT)
Hazard
Outer box labels for kit 0469247 correct, however the boxes contained the implants and jigs for 0468920
Sold states
NV
Affected count
1 kit
Manufactured in
600 Technology Park Dr, N/A, Billerica, MA, United States
Products
Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat: TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2849-2020Don't want to check this manually?
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