Device product
OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, REF ZBH-PSNCRCD39-R.
Z-0085-2019
Product summary
- Event
- Event 80845
- Status
- Terminated
- Classification
- Class II
- Quantity
- 36 devices
- Official record key
device-enforcement:Z-0085-2019
Official wording
Reason: Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.
Code information: Lot numbers 20598 and 20607, UDI 00816818021423.
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.