Recall Z-0463-2021 ยท OWI Bone Fixation Cerclage, Sublaminar
Medicrea International
MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to provide thoracic and/or lumbar posterior stabilization for degenerative pathologies Ref : A08200200
| Date | Oct 8, 2020 |
| Status | Terminated |
| Reason | 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 , |
| Root cause | 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 appropr |
| Quantity | 17 units US; 8 units OUS Expanded: 1 US and 3 OUS |
| Distribution | CA Foreign:France, Belgium |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.