Device product
OrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Right, REF ZBH-PSNCRGH712-R.
Z-0087-2019
Product summary
- Event
- Event 80845
- Status
- Terminated
- Classification
- Class II
- Quantity
- 68 devices
- Official record key
device-enforcement:Z-0087-2019
Official wording
Reason: Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.
Code information: Lot numbers 20566, 20567, 20609, and 20611, UDI 00816818021461.
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.