medical Class II Updated 2020-08-05

OrthoPediatrics Corp recalls Orthopedics 6.0MM ROD, COCR, SINGLE HEX, 500MM LENGTH-The RE

Recalled Product

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


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Number: 108332-A UDI: (01)0084113212400(10)108332A
View official government recall

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