Recall Z-0597-2018 ยท OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
OrthoPediatrics Corp
Response 5.5/6.0 Spine System 7.0mm x 40mm Pedicle Screw Product Usage: Posterior non-cervical pedicle screw fixation
| Date | Aug 3, 2017 |
| Status | Terminated |
| Reason | The 7mm diameter uniaxial pedicle screws have been color anodized with the same color utilized on 5 mm diameter screws. |
| Root cause | Employee error |
| Action | On August 4, 2017 an urgent medical device recall letter, titled "Response 5.5/6.0 Spine System - 7.0mm x 40mm UNIAXIAL PEDICLE SCREW" was issued to customers with instruction to quarantine affected product, which will be returned to the recalling firm for destruction. Questions or concerns can be directed to logistics@orthopediatrics.com or calling (574) 268-3692 |
| Quantity | 24 units |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150600 | Response 5.5/6.0 Spine System OrthoPediatrics Corp., May 22, 2015 |