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Nuvasive Specialized Orthopedics Inc recalls Precice Bone Transport - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthro
Recalled April 7, 2021 · FDA recall Z-1324-2021 · Nuvasive Specialized Orthopedics
Hazard
Due to complaints of adverse events potentially related to biological safety. The complaints included report of pain and bony abnormalities at the interface between the telescoping nail segments. · FDA Class II
Units
226 units
Sold at
Worldwide distribution - U.S. Nationwide distribution and the countries of Argentina, Austria, Belgium, Canada, Chile, Colombia, Cyprus, Denmark, Finland, France, Germany, Greece, Hong Kong, Israel, Italy, Luxemburg, Netherlands, Portugal, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey and UAE. Consignee List provided only includes email addresses. Complete contact information is pending.
Description
Due to complaints of adverse events potentially related to biological safety. The complaints included report of pain and bony abnormalities at the interface between the telescoping nail segments.
Product
Precice Bone Transport - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.
Manufacturer(s)
Nuvasive Specialized Orthopedics Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →