FDA-Device2022-04-20Class II
iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101
Conformis, Inc.
Hazard
Incorrect tibial base plate implant packaged in kit
Sold states
MS
Affected count
1 unit
Manufactured in
600 Technology Park Dr Ste 3, N/A, Billerica, MA, United States
Products
iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0899-2022Don't want to check this manually?
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