Device 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.
Z-0600-2018
Product summary
- Firm
- ConforMIS, Inc.
- Event
- Event 78902
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 units
- Official record key
device-enforcement:Z-0600-2018
Official wording
Reason: Implant kit mislabeled
Code information: Serial numbers: 0398482 & 0399917 Expiration Date: 12/31/2017
Distribution pattern: US Distribution to the states of :CA and TX.
Derived failure modes
-
Labeling or packaging
mislabeled