FDA-Device2018-02-21Class II
Total Knee Replacement , Catalog/Model # TPS-111-1111, UDI: +M572TPS1111111021/$$+31712310398482- and +M572TPS1111111021/$$+31712310399917/ Intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral, or bicompartmental prosthesis.
ConforMIS, Inc.
Hazard
Implant kit mislabeled
Sold states
US Distribution to the states of :CA and TX.
Affected count
2 units
Manufactured in
28 Crosby Dr, Bedford, MA, United States
Products
Total Knee Replacement , Catalog/Model # TPS-111-1111, UDI: +M572TPS1111111021/$$+31712310398482- and +M572TPS1111111021/$$+31712310399917/ Intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral, or bicompartmental prosthesis.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0600-2018Don't want to check this manually?
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