Device product
Verasense Knee System, Model SYK-TRCR 02. Intelligent disposable tibial insert that measures dynamic loads during orthopedic knee surgery.
Z-1029-2015
Product summary
- Event
- Event 69963
- Status
- Terminated
- Classification
- Class II
- Quantity
- 22 devices
- Official record key
device-enforcement:Z-1029-2015
Official wording
Reason: Presence of one inoperable (dead) sensor pad.
Code information: Model SYK-TRCR 02, Lot # 091914V11770, Serial #s: 411654008, 411585023, 411654007, 411585032, 411585014, 411654016, 411585017, 411654015, 411585030, 411654020, 411654004, 411654010, 411585007, 411585005, 411654011, 411585036, 411585035, 411654018, 411654012, 411585011, 411654014, 411654005, 411654001, 411585003.
Distribution pattern: US Distribution to the states of : IL, MI, NY, CA, VA and NV.
Derived failure modes
-
Unknown
Presence of one inoperable (dead) sensor pad.