CLASS II Device recall · Reported 25 Nov 2020 · FDA Enforcement Report
Medicrea Ligapass Tension Pulley Handle XS- intended to recalled
Medicrea International is recalling Medicrea Ligapass Tension Pulley Handle XS- intended to provide thoracic and/or lumbar, distributed in California. The recall was initiated on 8 Oct 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0463-2021
- FDA event ID
- 86657
- Recalling firm
- Medicrea International, Rillieux La Pape, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Oct 2020
- FDA classified
- 17 Nov 2020
- Reported
- 25 Nov 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Lead & Heavy Metals
- Device type
- Other Medical Devices
Timeline
| 8 Oct 2020 | Recall initiated by company | |
| 17 Nov 2020 | Classified by FDA | +40 days |
| 25 Nov 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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 ,
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to provide thoracic and/or lumbar posterior stabilization for degenerative pathologies Ref : A08200200
Where it was distributed
CA Foreign:France, Belgium
Questions about this recall
Is Medicrea Ligapass Tension Pulley Handle XS- intended to provide thoracic and/or lumbar recalled?
Yes. Medicrea International recalled Medicrea Ligapass Tension Pulley Handle XS- intended to provide thoracic and/or lumbar on 8 Oct 2020. The recall is Class II and its status is Terminated. Recall number Z-0463-2021.
Why was it recalled?
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 ,
Which lots are affected?
Lot Numbers: US: 17E0550-1, 17E1089R/2, 18E0278, OUS: 19B0962, 19B0595, 19B0601 Expanded Recall: 11/3/20 17E0550/2, 19B0602, 19B0963 and 19B0964
Where was it sold?
CA Foreign:France, Belgium
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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