Medicrea International Vancia Vancia Rillieux La Pape France MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to provide thoracic and/or lumbar posterior stabilization for degenerative pathologies Ref : A08200200 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to provide thoracic and/or lumbar posterior stabilization for degenerative pathologies Ref : A08200200
Brand
Medicrea International Vancia Vancia Rillieux La Pape France
Lot Codes / Batch Numbers
Lot Numbers: US: 17E0550-1, 17E1089R/2, 18E0278, OUS: 19B0962, 19B0595, 19B0601 Expanded Recall: 11/3/20 17E0550/2, 19B0602, 19B0963 and 19B0964
Products Sold
Lot Numbers: US: 17E0550-1, 17E1089R/2, 18E0278, OUS: 19B0962, 19B0595, 19B0601 Expanded Recall: 11/3/20 17E0550/2, 19B0602, 19B0963 and 19B0964
Medicrea International Vancia Vancia Rillieux La Pape France is recalling MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to provide thoracic and/or lumbar posterior sta due to 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 r. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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 ,
Recommended Action
Per FDA guidance
Medicrea International issued Reportable voluntary Recall notification dated 10/5/20 to via e-mail to distributors and subsidiaries stating reason for recall, health risk and action to take: Instructions sent to US subsidiary : 1. Immediately check your internal inventory and quarantine all subject devices pending return to MEDICREA 2. Circulate this Field Safety Notice internally to all interested/affected parties. 3. Inform MEDICREA if any of the subject devices have been distributed to other organisations. a) Please provide contact details so that MEDICREA can inform the recipients appropriately. b) If you are a Distributor, note that you are responsible for notifying your affected customers. 4. Please inform MEDICREA of any adverse events concerning the use of the subject devices Please comply with any local laws or regulations concerning the notification of adverse events to your National Competent Authority. 5. Complete the attached customer response form. It may be that you no longer have any physical inventory on site. Completing this form will allow us to update our records and will also negate the need for us to send any further unnecessary communications on this matter. Therefore please complete even if you no longer have any of the subject devices in your physical inventory. Contact: Karine TROGNEUX MEDICREA INTERNATIONAL Regulatory Affairs Manager, Direct : +33(0)4.69.85.95.39 Standard : +33 (0)4.72.01.87.87. Fax - N +33 (0)04 72 01 87 88 Mail : ktrogneux@medicrea.com
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA
Page updated: Jan 10, 2026