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)
Conformis, Inc.
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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