Z-0463-2021Class II

MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to provide thoracic and/or lumbar posterior...

Name: Z-0463-2021 MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to provide thoracic and/or lumbar posterior...
Creator: Medicrea International
Published: 2020-10-08
License: https://open.fda.gov/license/

Medicrea International / initiated 2020-10-08 / Terminated / root cause: design

FDA source

Medicrea International began a recall of MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to provide thoracic and/or lumbar posterior stabilization for degenerative pathologies Ref : A08200200 on 2020-10-08. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0463-2021
Classification: Class II
Status: Terminated
Initiated: 2020-10-08
Posted: 2020-11-17
Terminated: 2024-05-09
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
Product code: OWI Bone Fixation Cerclage, Sublaminar
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 ,
Root cause tag: design
FDA 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 : [email protected]
Quantity in commerce: 17 units US; 8 units OUS Expanded: 1 US and 3 OUS
Distribution: CA Foreign:France, Belgium
Product codes and lots: Lot Numbers: US: 17E0550-1, 17E1089R/2, 18E0278, OUS: 19B0962, 19B0595, 19B0601 Expanded Recall: 11/3/20 17E0550/2, 19B0602, 19B0963 and 19B0964

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0463-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0463-2021	Class II	Terminated	Voluntary: Firm initiated	2020-11-25	2020-11-17

Product code OWI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)