Device product
OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, REF ZBH-PSNCREF311-L.
Z-0082-2019
Product summary
- Event
- Event 80845
- Status
- Terminated
- Classification
- Class II
- Quantity
- 41 devices
- Official record key
device-enforcement:Z-0082-2019
Official wording
Reason: Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.
Code information: Lot numbers 20568, 20575, 20581, 20584, 20621, 20623, and 20628, UDI 00816818021430.
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.