FDA-Device2019-04-10Class II
iTotal Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-111-1111 - 020102
Conformis, Inc.
Hazard
The labeling of the boxes and sterile pouches did not match the contents.
Sold states
The products were distributed to the following US states: NH. The products were distributed to the following foreign countries: Germany
Affected count
2
Manufactured in
600 Technology Park Dr, N/A, Billerica, MA, United States
Products
iTotal Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-111-1111 - 020102
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1079-2019Don't want to check this manually?
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