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
- Recall Number
- Z-0600-2018
- Event Number
- 78902
- Firm
- ConforMIS, Inc.
- FEI Number
- 3009844603
- Product Code
- JWH
- Status
- Terminated
- Root Cause
- Employee error
- Initiated
- July 24, 2017
- Terminated
- February 1, 2019
- Address
- 28 Crosby Dr, Bedford, MA, 01730-1402
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.
Implant kit mislabeled
On July 10, 2017, ConforMIS notified their Sales Representatives about a possible product mislabeling. On July 11, 2017, ConforMIS secured impacted product. On July 21, 2017, ConforMIS issued a Memorandum to their Sales Representatives. ConforMIS requested that the kits be returned to ConforMIS for investigation and disposition. For further questions, please call (781) 345-9001.
US Distribution to the states of :CA and TX.
2 units