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OrthoPediatrics Corp recalls Response 5.5/6.0 Spine System 7.0mm x 40mm Pedicle Screw Product Usage: Posterior non-cervical pedicle screw fixa
Recalled February 21, 2018 · FDA recall Z-0597-2018 · OrthoPediatrics
Hazard
The 7mm diameter uniaxial pedicle screws have been color anodized with the same color utilized on 5 mm diameter screws. · FDA Class II
Units
24 units
Sold at
US Nationwide Distribution
Description
The 7mm diameter uniaxial pedicle screws have been color anodized with the same color utilized on 5 mm diameter screws.
Product
Response 5.5/6.0 Spine System 7.0mm x 40mm Pedicle Screw Product Usage: Posterior non-cervical pedicle screw fixation
Manufacturer(s)
OrthoPediatrics Corp
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →