MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to provide… — Class II medical device recall Z-0463-2021
Terminated recall by Medicrea International, reported 2020-11-25, distributed in CA. Tightening the LIGAPASS Band with this instrument, the tensioner's pliers can crush the band causing the band
| Recall number | Z-0463-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medicrea International, Rillieux La Pape, N/A, France |
| Recall initiated | 2020-10-08 |
| Classified | 2020-11-17 |
| Reported by FDA | 2020-11-25 |
| Terminated | 2024-05-09 |
| Distributed | CA |
| Countries outside the US | BE, FR |
| Reason classes | device malfunction |
| Lot numbers | 17E0550-1, 17E1089R/2, 18E0278, 19B0595, 19B0601, 19B0962 |
| Model numbers | A08200200 |
Product
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 ,
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0463-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.