Recall Z-0622-2016— OrthoPediatrics Corp

Name: FDA recall Z-0622-2016
Creator: U.S. Food and Drug Administration
Published: 2015-11-10

Class II · Terminated

Class II FDA medical device recall by OrthoPediatrics Corp, initiated 2015-11-10, terminated 2016-05-23. It names one FDA 510(k) clearance: K150600. 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.. Reason: 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..

Recalling firm: OrthoPediatrics Corp
Classification: Class II
Status: Terminated
Initiated: 2015-11-10
Terminated: 2016-05-23
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K150600 — Response 5.5/6.0 Spine SystemOrthoPediatrics Corp.·cleared 2015-05-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.