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U.S. Department of Health and Human Services

Class 2 Device Recall MEDICREA LIGAPASS TENSION PULLEY HANDLE XS

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  Class 2 Device Recall MEDICREA LIGAPASS TENSION PULLEY HANDLE XS see related information
Date Initiated by Firm October 08, 2020
Create Date November 17, 2020
Recall Status1 Terminated 3 on May 09, 2024
Recall Number Z-0463-2021
Recall Event ID 86657
Product Classification Bone fixation cerclage, sublaminar - Product Code OWI
Product MEDICREA LIGAPASS TENSION PULLEY HANDLE XS-
intended to provide thoracic and/or lumbar posterior stabilization for degenerative pathologies
Ref : A08200200
Code Information Lot Numbers: US: 17E0550-1, 17E1089R/2, 18E0278, OUS: 19B0962, 19B0595, 19B0601  Expanded Recall: 11/3/20 17E0550/2, 19B0602, 19B0963 and 19B0964
Recalling Firm/
Manufacturer		 Medicrea International
Vancia
Vancia
Rillieux La Pape France
Manufacturer 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 ,
FDA Determined
Cause 2		 Device Design
Action 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
Quantity in Commerce 17 units US; 8 units OUS Expanded: 1 US and 3 OUS
Distribution CA Foreign:France, Belgium
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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