FDA Enforcement
Class II
Terminated
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.
Recall: Z-0600-2018
·
Reported February 21, 2018
Enforcement
- Recall Number
- Z-0600-2018
- Event ID
- 78902
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- ConforMIS, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Telephone
- Report Date
- February 21, 2018
- Initiation Date
- July 24, 2017
- Classification Date
- February 13, 2018
- Termination Date
- February 1, 2019
- Address
- 28 Crosby Dr, Bedford, MA, 01730-1402, United States
Description
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.
Reason
Implant kit mislabeled
Code Info
Serial numbers: 0398482 & 0399917 Expiration Date: 12/31/2017
Distribution
US Distribution to the states of :CA and TX.
Quantity
2 units