Device product
OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, REF ZBH-PSNCREF311-R.
Z-0083-2019
Product summary
- Event
- Event 80845
- Status
- Terminated
- Classification
- Class II
- Quantity
- 37 devices
- Official record key
device-enforcement:Z-0083-2019
Official wording
Reason: Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.
Code information: Lot numbers 20569, 20576, 20594, and 20618, UDI 00816818021447.
Distribution pattern: Distribution was made CA, FL, IL, IN, MI, NY, and NC. Foreign distribution was made to Australia. There was no government/military distribution.
Derived failure modes
-
Unknown
Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.