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PRECICE® Intramedullary Limb Lengthening System Instrument

NUVASIVE SPECIALIZED ORTHOPEDICS, INC. · Model RMB1-000 · UDI-DI 00812258022143

HXL Prescription
3
510(k) clearances
75
Adverse events
1
Recalls
202
Facilities

Description

Orthopedic surgical instrument (mallet) - for use with the intramedullary limb lengthening system

Recalls

DateFirmReason
2021-07-21Implant Resource IncPotential for mallet head to become separated from mallet handle. There is also significant deformations on striking surface that were not expected

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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.