Medicrea Ligapass Tension Pulley Handle Recalled for Band Breakage Risk
Medicrea International is recalling Ligapass Tension Pulley Handles because the instrument can crush the band, causing it to break during surgery and leading to infection risk.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria for theoretical or unreported harm.
Plain-English summary
Medicrea International is recalling the Ligapass Tension Pulley Handle XS (Ref: A08200200). This medical device is intended to provide thoracic and/or lumbar posterior stabilization for degenerative pathologies. The recall affects 17 units in the United States and 8 units outside the US, with an expanded recall adding 1 US unit and 3 units outside the US. Distribution includes California, France, and Belgium.
The recall is issued because tightening the Ligapass Band with this instrument can cause the tensioner's pliers to crush the band. This crushing can cause the band to break during surgery. The source text states that this failure leads to a risk of infection and re-intervention.
Healthcare providers and patients should stop using the affected devices. Specific lot numbers for the US include 17E0550-1, 17E1089R/2, and 18E0278, with expanded lots 17E0550/2. Specific lot numbers for outside the US include 19B0962, 19B0595, and 19B0601, with expanded lots 19B0602, 19B0963, and 19B0964.
The recalled product
- Product
- MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to provide thoracic and/or lumbar posterior stabilization for degenerative pathologies Ref : A08200200
- Manufacturer
- Medicrea International
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Lot Numbers: US: 17E0550-1
- 17E1089R/2
- 18E0278
- OUS: 19B0962
- 19B0595
- 19B0601 Expanded Recall: 11/3/20 17E0550/2
- 19B0602
- 19B0963 and 19B0964
Distribution
Distributed in 1 state:
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