Z-0064-2014Class II

SmartSet Endurance GMV, Gentamicin, REF 3105-040, Medium Viscosity Antibiotic Bone Cement, Sterile. SmartSet...

Name: Z-0064-2014 SmartSet Endurance GMV, Gentamicin, REF 3105-040, Medium Viscosity Antibiotic Bone Cement, Sterile. SmartSet...
Creator: DePuy Orthopaedics, Inc.
Published: 2013-09-16
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2013-09-16 / Terminated / root cause: labeling and UDI

FDA source

DePuy Orthopaedics, Inc. began a recall of SmartSet Endurance GMV, Gentamicin, REF 3105-040, Medium Viscosity Antibiotic Bone Cement, Sterile. SmartSet GMV Endurance Gentamicin, bone cements are... on 2013-09-16. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0064-2014
Classification: Class II
Status: Terminated
Initiated: 2013-09-16
Posted: 2013-10-23
Terminated: 2015-02-24
Recalling firm: Depuy Orthopaedics Inc.
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.
Product code: MBB Bone Cement, Antibiotic
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
Root cause tag: labeling and UDI
FDA root cause: No Marketing Application
Action: The firm DePuy Synthes, sent an "URGENT INFORMATION-MEDICAL DEVICE RECALL NOTICE" dated September 16, 2013 to its consignees via E-mail, hand delivery or fax depending on the most appropriate delivery method for each consignees. The Urgent recall notice described the recalled product, explained the reason for the recall, and directed consignees to cease further distribution, complete the attached Reconciliation form and quarantine and return all affected products through the DePuy Orthopaedics Sales consultant, Fax 1-787-287-7681 or Email to [email protected]. Consignees were directed to maintain a copy of the notice and forward the notice if product was further distributed. Clinical questions should be addressed to DePuy Orthopaedics, Inc's Scientific Information Office at 1-888-554-2482 (M-F; 8 a.m. - 5 p.m. EDT). Recall questions or concerns should be addressed to the Quality & Compliance Supervisor, at 1-787- 272-1900 x3114 or [email protected] (MF; 8 am- 5 pm EST).
Quantity in commerce: 16,040 units
Distribution: Distributed in Puerto Rico and US Virgin Islands.
Product codes and lots: .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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0064-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0064-2014	Class II	Terminated	Voluntary: Firm initiated	2013-10-30	2013-10-23

Product code MBB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)