Recall archive
4 recalls · page 1 of 1
Reported Jun 25, 2025
REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Orthofix Srl
Matched: Brand — Retrospective; Their is the potential that implantable intramedullary lengthening nails may bend at the distal tail during insertion resulting in…
FDA (openFDA device enforcement)
Reported Nov 20, 2019
ORTHOFIX Catalogue Number: ref 11007, drill bit diameter 4.8 MM LENGTH 280 MM, RX ONLY, Non Sterile, UDI:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Orthofix Srl
Matched: Brand · Product · Product details — As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the…
30 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 13, 2018
TL-HEX TruLok Hexapod System, Double Row Footplates, TL-HEX Sterile, All Sizes: 120 MM, 140 MM, 160 MM, 180 MM, 200 MM.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Orthofix Srl
Matched: Brand — The firm received complaints regarding the incompatibility and dimensional interference between the double row footplates manufactured in a limited…
FDA (openFDA device enforcement)
Reported Jan 3, 2018
Orthofix Power Drill Torque Limiter, Sterile, Rx Only, Single Use; Sold individually and in the Galaxy UNYCO Diaphyseal…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Orthofix Srl
Matched: Brand · Product · Product details — The power drill torque limiter may break during use in surgery application.
FDA (openFDA device enforcement)
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