MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to recall
MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to provide thoracic and/or lumbar posterior stabilization for degenerative pathologies Ref…
Why was MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to 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 ,
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models 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
- Product
- MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to provide thoracic and/or lumbar posterior stabilization for degenerative pathologies Ref…
- Recalling firm
- Medicrea International
- Quantity
- 17 units US; 8 units OUS Expanded: 1 US and 3 OUS
- Distribution
- CA Foreign:France, Belgium
- Recall date
- November 25, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)