FDA recall Z-0899-2022
Conformis, Inc. · Class II · device
Product
iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101
Reason for recall
Incorrect tibial base plate implant packaged in kit
Distribution
MS
Key facts
- Status
- Completed
- Initiation date
- 2022-02-22
- Report date
- 2022-04-20
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Billerica, MA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0899-2022