Recall Z-0064-2014— DePuy Orthopaedics, Inc.

Class II FDA medical device recall by DePuy Orthopaedics, Inc., initiated 2013-09-16, terminated 2015-02-24. FDA's recall record names no specific 510(k) clearance for this event. Product: SmartSet¿ Endurance GMV, Gentamicin, REF 3105-040, Medium Viscosity Antibiotic Bone Cement, Sterile. SmartSet GMV Endurance Gentamicin, bone cements are self-curing, radiopaque, polymethyl methacrylate based cements, containing antibiotic, used for securing a metal or polymeric prosthesis to living bone in arthroplasty procedures where infection by gentamicin-sensitive organisms is a potential risk.. Reason: The SmartSet¿ GMV Endurance Gentamicin Bone Cement, product ref: number 3105-040 is intended for use in indications that have not been cleared by the US FDA. The intended use stated in the IFU for the SmartSet¿ GMV Endurance Gentamicin Bone Cement is for the fixation of prostheses to living bone in arthroplasty procedures of joints in which infection by gentamicin-sensitive organisms is a potentia.

Recalling firm

DePuy Orthopaedics, Inc.

Classification

Class II

Status

Terminated

Initiated

2013-09-16

Terminated

2015-02-24

Firm location

Warsaw, IN, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.