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ConforMIS, Inc. recalls Total Knee Replacement , Catalog/Model # TPS-111-1111, UDI: +M572TPS1111111021/$$+31712310398482- and +M572TPS1111111021
Recalled February 21, 2018 · FDA recall Z-0600-2018 · ConforMIS
Hazard
Implant kit mislabeled · FDA Class II
Units
2 units
Sold at
US Distribution to the states of :CA and TX.
Description
Implant kit mislabeled
Product
Total Knee Replacement , Catalog/Model # TPS-111-1111, UDI: +M572TPS1111111021/$$+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.
Manufacturer(s)
ConforMIS, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →