CLASS II Device recall · Reported 30 Oct 2013 · FDA Enforcement Report
SmartSet¿ Endurance GMV, Gentamicin recalled by DePuy Orthopaedics
DePuy Orthopaedics is recalling SmartSet¿ Endurance GMV, Gentamicin, distributed in Puerto Rico. The recall was initiated on 16 Sep 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0064-2014
- FDA event ID
- 66248
- Recalling firm
- DePuy Orthopaedics, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Sep 2013
- FDA classified
- 23 Oct 2013
- Reported
- 30 Oct 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Hip & Knee Implants
Timeline
| 16 Sep 2013 | Recall initiated by company | |
| 23 Oct 2013 | Classified by FDA | +37 days |
| 30 Oct 2013 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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.
Where it was distributed
Distributed in Puerto Rico and US Virgin Islands.
Questions about this recall
Is SmartSet¿ Endurance GMV, Gentamicin recalled?
Yes. DePuy Orthopaedics recalled SmartSet¿ Endurance GMV, Gentamicin on 16 Sep 2013. The recall is Class II and its status is Terminated. Recall number Z-0064-2014.
Why was it 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
Which lots are affected?
.Lot #s: 1866567 2492886 2844909 3106436 3299572 3434618 F049Z40 1890991 2521804 2866892 3115022 3310546 3466958 1927220 2585596 2888115 3134757 3339992 3475370 1933603 2589374 2889319 3166736 3347549 3483245 1985488 2589379 2981608 3175434 3362229 3498627 2047388 2610503 2991395 3205074 3378764 3528522 2064474 2610505 3011228 3223183 3380098 3572240 2332458 2641279 3042105 3236354 3403313 3572270 2354798 2803352 3062608 3249497 3412748 3590469 2374539 2839097 3078622 3249526 3416122 F024ZA40
Where was it sold?
Distributed in Puerto Rico and US Virgin Islands.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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