Reported Oct 30, 2013 · Terminated
SmartSet¿ Endurance GMV, Gentamicin, REF 3105-040, Medium Viscosity Antibiotic Bone Cement, Sterile. SmartSet GMV…
DePuy Orthopaedics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: DePuy Orthopaedics, Inc. · 700 Orthopaedic Dr · Warsaw, IN · 46582-3994
Is this the product you have?
- 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.
- Lot codes and dates
- .Lot #s:
61 of 61 codes
186656724928862844909310643632995723434618F049Z4018909912521804286689231150223310546346695819272202585596288811531347573339992347537019336032589374288931931667363347549348324519854882589379298160831754343362229349862720473882610503299139532050743378764352852220644742610505301122832231833380098357224023324582641279304210532363543403313357227023547982803352306260832494973412748359046923745392839097307862232495263416122
- .Lot #s:
- Amount recalled
- 16,040 units
Where it was sold
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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