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OrthoPediatrics Corp recalls UniAxial Pedicle Screw & UniAxial Reduction Pedicle Screw The Response 5.5/6.0 Spine System is intended for immobiliz
Recalled January 20, 2016 · FDA recall Z-0622-2016 · OrthoPediatrics
Hazard
Response Spine UniAxial Pedicle & UniAxial Reduction Pedicle Screws may have been manufactured incorrectly, thus preventing the driver from fully engaging into the hexagonal drive feature of the screw. · FDA Class II
Units
102
Sold at
US Distribution to states of: AL, AZ, CA, DE, FL, GA, HI, KY, LA, MI, MO, MN, MS, NC, NJ, NY, OH, OR, TN, and TX.
Description
Response Spine UniAxial Pedicle & UniAxial Reduction Pedicle Screws may have been manufactured incorrectly, thus preventing the driver from fully engaging into the hexagonal drive feature of the screw.
Product
UniAxial Pedicle Screw & UniAxial Reduction Pedicle Screw The Response 5.5/6.0 Spine System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.
Manufacturer(s)
OrthoPediatrics Corp
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →