FDA Device recall Z-0463-2021
MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to provide thoracic and/or lumbar posterior stabilization for degenerative pathologies…
- FDA Device
- Class II
- terminated
- Published 2020-11-25
On 2020-11-25 the FDA classified a Class II recall of MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to provide thoracic and/or lumbar posterior stabilization for degenerative pathologies… by Medicrea International, citing 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-interv….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0463-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-10-08 |
| Published | 2020-11-25 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Medicrea International |
| Distribution | CA |
Product
MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to provide thoracic and/or lumbar posterior stabilization for degenerative pathologies Ref : A08200200
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 ,
Identifiers
| code_info | Lot Numbers: US: 17E0550-1, 17E1089R/2, 18E0278, OUS: 19B0962, 19B0595, 19B0601 Expanded Recall: 11/3/20 17E0550/2, 19B0602, 19B0963 and 19B0964 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0463-2021%22
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