Recall Z-0622-2016 ยท NKB Thoracolumbosacral Pedicle Screw System
OrthoPediatrics Corp
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
| Date | Nov 10, 2015 |
| Status | Terminated |
| 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. |
| Root cause | Process change control |
| Action | The firm, OrthoPediatrics Corp., sent an "URGENT MEDICAL DEVICE RECALL" letter dated 11/13/2015 to affected customers via email. The letter included a description of the reason for the recall, affected product, consignee responsibilities, and actions to be taken. The customers were instructed to take immediate possession of all the identified devices; quarantine them and immediately return them to OrthoPediatrics, and complete and return the Mandatory Reply Form via fax to (574) 269-3692 or email: MF0x@OrthoPediatrics.com. If you have any questions, please contact VP-Regulatory Affairs (574) |
| Quantity | 102 |
| Distribution | 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. |
| 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 |