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

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

Code information: Lot Number: 108332-A UDI: (01)0084113212400(10)108332A

Distribution pattern: US Nationwide distribution including in the states of Al, CA, FL, GA, KY, MI, MO, NC, NY, OH, TX.