Reported Nov 25, 2020 · Terminated
MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to provide thoracic and/or lumbar posterior stabilization for…
Medicrea International
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medicrea International · Vancia · Rillieux La Pape, N/A · N/A
Is this the product you have?
- MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to provide thoracic and/or lumbar posterior stabilization
- for degenerative pathologies RefA08200200
- Lot codes and dates
- Lot Numbers
US: 17E0550-117E1089R/218E0278
- OUS
19B096219B059519B0601
- Expanded Recall
11/3/20 17E0550/219B060219B0963 and 19B0964
- Lot Numbers
- Amount recalled
- 17 units US; 8 units OUS Expanded: 1 US and 3 OUS
Where it was sold
Why it was 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 ,
This product could cause temporary or reversible health problems — stop using it.
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