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

Product may have incorrect laser etched alignment lines, the non-conforming laser etch may have compromised strength, lead to unintended fracture of the device

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 understanding of these instructions. Any questions regarding this recall can be directed to Kriss Anderson, VP of Quality Systems and Regulatory Affairs, at OrthoPediatrics at [email protected] or 574-267-0897