Z-0463-2021 Class II Terminated
FDA device recall Z-0463-2021 was initiated by Medicrea International on October 8, 2020 and is designated Class II. Reason for recall: 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 , The recall status is terminated (terminated May 9, 2024). Affected quantity: 17 units US; 8 units OUS Expanded: 1 US and 3 OUS.
Recall Details
- Product Type
- Devices
- Report Date
- November 25, 2020
- Initiation Date
- October 8, 2020
- Termination Date
- May 9, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17 units US; 8 units OUS Expanded: 1 US and 3 OUS
Product Description
MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to provide thoracic and/or lumbar posterior stabilization for degenerative pathologies Ref : A08200200
Reason for Recall
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 ,
Distribution Pattern
CA Foreign:France, Belgium
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