Device product
MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to provide thoracic and/or lumbar posterior stabilization for degenerative pathologies Ref : A08200200
Z-0463-2021
Product summary
- Event
- Event 86657
- Status
- Terminated
- Classification
- Class II
- Quantity
- 17 units US; 8 units OUS Expanded: 1 US and 3 OUS
- Official record key
device-enforcement:Z-0463-2021
Official wording
Reason: Tightening the LIGAPASS Band with this instrument, the tensioner's pliers can crush the band causing the band to break during surgery and lead to a risk of infection and re-intervention ,
Code information: Lot Numbers: US: 17E0550-1, 17E1089R/2, 18E0278, OUS: 19B0962, 19B0595, 19B0601 Expanded Recall: 11/3/20 17E0550/2, 19B0602, 19B0963 and 19B0964
Distribution pattern: CA Foreign:France, Belgium
Derived failure modes
-
Unknown
Tightening the LIGAPASS Band with this instrument, the tensioner's pliers can crush the band causing the band to break during surgery and lead to a risk of infection and re-intervention ,