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.
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 ,
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.
The tensioner's pliers can crush the surgical band when tightened, causing it to break during surgery. This breakage may lead to infection or the need for re-intervention.
Surgical teams using the LIGAPASS Tension Pulley Handle XS- for spinal stabilization procedures are affected. Patients undergoing surgery with this device are at risk of infection or needing additional procedures.
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.
Look for lot numbers on the device: US lots 17E0550-1, 17E1089R/2, 18E0278 or OUS lots 19B0962, 19B0595, 19B0601.
Reach out to Medicrea International for further guidance on the recall.
The tensioner's pliers can crush the surgical band during tightening, causing it to break during surgery and potentially leading to infection or re-intervention.
US lot numbers: 17E0550-1, 17E1089R/2, 18E0278; OUS lot numbers: 19B0962, 19B0595, 19B0601.
The recall record does not specify a remedy, so no immediate fix is provided.
We’ve drafted a message you can send Medicrea to request your refund or repair — edit it as you like.
Subject: Recall Z-0463-2021 — Medicrea Medicrea Hello, I own a Medicrea that is covered by recall Z-0463-2021 from Medicrea. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
