FDA Medical Device Recalls (openFDA)
Medicrea International: MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to provide thoracic and/or lumbar posterior stabilization for degenerative pathologies Ref : A08200200
- Recall number
- Z-0463-2021
- Recalling firm
- Medicrea International
- Product
- MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to provide thoracic and/or lumbar posterior stabilization for degenerative pathologies Ref : A08200200
- Status
- Terminated
- Initiated
- 2020-10-08
- Posted
- not on file
- Terminated
- 2024-05-09
- 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 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
- 17 units US; 8 units OUS Expanded: 1 US and 3 OUS
- Distribution
- CA Foreign:France, Belgium
- Lot, serial or model codes
- Lot Numbers: US: 17E0550-1, 17E1089R/2, 18E0278, OUS: 19B0962, 19B0595, 19B0601 Expanded Recall: 11/3/20 17E0550/2, 19B0602, 19B0963 and 19B0964
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OWI
- Firm FEI
- 1000432246
- Firm city
- Vancia Vancia Rillieux La Pape
- Firm state
- not on file
- Firm country
- France
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28