ResCUBE™

COUSIN BIOTECH · Model RCBCUBETUU · UDI-DI 03760185576109

OWI Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

The ResCUBE™ System is a temporary spinal implant intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. It consists of: - A ligament allowing correction and stabilization of the levels, after tensioning - A malleable leader allowing guidance of the ligament during surgery and attached to the ligament by a PET sheath. The lamella and shrink sleeve are not intended for long term implantation and must be removed after placement of the implant. - A low-profile connector holding the tension on the ligament

Recalls

Date	Firm	Reason
2020-10-08	Medicrea International	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-interv
2017-04-24	OrthoPediatrics Corp	Over-tensioning of the band resulting in damage to the band causing it to rupture

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.