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Bone Fixation Cerclage, Sublaminar

FDA product code OWI · Class 2 · Orthopedic

353
Registered devices
68
Adverse events
2
Recalls
37
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2020-10-08Medicrea InternationalTightening 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 inf
2017-04-24OrthoPediatrics CorpOver-tensioning of the band resulting in damage to the band causing it to rupture

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.