Use caution Medical device recall · FDA · Published October 8, 2020

Medicrea LIGAPASS Tension Pulley Handle XS- Recall: Risk of Band Breakage During Surgery

Medicrea recalls LIGAPASS Tension Pulley Handle XS- for potential band breakage during surgery, risking infection and reoperation. Affected units have specific lot numbers and were sold from 2017-2019.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0463-2021Medical device Medicrea ›

Use caution until it’s fixed

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 ,

Take action

Contact the company

Recalling firmMedicrea InternationalVancia, Vancia · Rillieux La Pape, France

✎ GovInfoNow plain-language explainer

Medicrea is recalling its LIGAPASS Tension Pulley Handle XS- device because tightening it with the instrument can cause the surgical band to break during procedures. This poses a risk of infection and needing additional surgery. Read more at govinfonow.com/recall/64112-medicrea-ligapass-tension-pulley-handle-xs-recall-risk-of-band.

Source Summary by GovInfoNow · govinfonow.com/recall/64112-medicrea-ligapass-tension-pulley-handle-xs-recall-risk-of-band · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0463-2021

Cite this page

“Medicrea LIGAPASS Tension Pulley Handle XS- Recall: Risk of Band Breakage During Surgery.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64112-medicrea-ligapass-tension-pulley-handle-xs-recall-risk-of-band. Based on FDA recall #Z-0463-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0463-2021%22&limit=1).

The FDA announced on 2020-10-08 that Medicrea International is recalling the MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- due to a Class II device hazard. The instrument can crush and break the tension band during surgery, leading to infection and re-intervention risks.

How to tell if you have it

Brand: Medicrea
Product: MEDICREA LIGAPASS TENSION PULLEY HANDLE XS-
Ref: A08200200
Lot Numbers (US): 17E0550-1, 17E1089R/2, 18E0278, 17E0550/2
Lot Numbers (OUS): 19B0962, 19B0595, 19B0601, 19B0602, 19B0963, 19B0964
Distribution: CA, France, Belgium

The hazard

According to the FDA, tightening the LIGAPASS Band with this instrument can cause the tensioner's pliers to crush the band, causing it to break during surgery. This failure leads to a risk of infection and re-intervention.

Context

GovInfoNow's records show Medicrea International has had 8 other recalls since 2019-06-27. Recent brand recalls include the 2025-10-29 IB3D PL Instruments Set recall for handles that may untread from the shaft and the 2024-12-03 UNiD Spine Analyzer Software Error Recall involving incorrect surgical calculations. Other recent recalls of similar products include the 2025-12-09 Intuitive Surgical da Vinci S/Si Grasping Retractor Instruments recall for broken grip cables and the 2025-12-04 Merit Medical Custom Procedure Kit recall where handles may detach during use.

How to tell if you have this one

Check the lot numbers: US lots 17E0550-1, 17E1089R/2, 18E0278 and OUS lots 19B0962, 19B0595, 19B0601. The device was sold between 2017 and 2019.

Brand
Medicrea
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Lot Number
Look for lot numbers on the device: US lots 17E0550-1, 17E1089R/2, 18E0278 or OUS lots 19B0962, 19B0595, 19B0601.
Contact Manufacturer
Reach out to Medicrea International for further guidance on the recall.

Where it went and when

Where it was distributed

Distributed in California, and outside the U.S.

FDA distribution: “CA Foreign:France, Belgium” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: California.

Recall timeline

FDA terminated this recall 3.6 years after the firm started it.

Oct 8, 2020Firm started the recall
Nov 17, 2020FDA classified it Class II
Nov 25, 2020Published in FDA’s Enforcement Report
May 9, 2024FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/64112-medicrea-ligapass-tension-pulley-handle-xs-recall-risk-of-band">Medicrea LIGAPASS Tension Pulley Handle XS- Recall: Risk of Band Breakage During Surgery (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0463-2021 (October 8, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0463-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.