Recall Z-2742-2020 ยท NKB Thoracolumbosacral Pedicle Screw System
OrthoPediatrics Corp
Orthopedics 6.0MM ROD, COCR, SINGLE HEX, 500MM LENGTH-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 Model Number: 00-1300-6053
| Date | Jul 6, 2020 |
| Status | Open, Classified |
| Reason | Product may have incorrect laser etched alignment lines, the non-conforming laser etch may have compromised strength, lead to unintended fracture of the device |
| Root cause | Under Investigation by firm |
| Action | Orthopedics issued Field Action Notice distributed via email on July 6, 2002 stating reason for recall , heath risk and action to take: Distributors are required, to perform sub-recall. The affected product must be returned to OrthoPediatrics Corporation. Replacement product will be provided. Please contact customer service to arrange return of the affected product. Distributors should retrieve affected product that may be with customers. No additional corrective actions need to be taken for product already implanted. Please complete and return the attached response form confirming your under |
| Quantity | 73 units |
| Distribution | US Nationwide distribution including in the states of Al, CA, FL, GA, KY, MI, MO, NC, NY, OH, 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 |