Z-1246-2015Class II

SMARTSET GHV Gentamicin Bone Cement. A self-curing, radiopaque, polymethyl methacrylate based cement...

Name: Z-1246-2015 SMARTSET GHV Gentamicin Bone Cement. A self-curing, radiopaque, polymethyl methacrylate based cement...
Creator: DePuy Orthopaedics, Inc.
Published: 2015-02-11
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2015-02-11 / Terminated / root cause: packaging

FDA source

DePuy Orthopaedics, Inc. began a recall of SMARTSET GHV Gentamicin Bone Cement. A self-curing, radiopaque, polymethyl methacrylate based cement containing antibiotic. It is used for securing a metal or... on 2015-02-11. FDA classified it as Class II and gives the reason as "One lot of SMARTSET GHV Gentamicin Bone Cement is partially agglomerated . This may result in surgical delays while a replacement package of cement is retrieved and mixed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1246-2015
Classification: Class II
Status: Terminated
Initiated: 2015-02-11
Posted: 2015-03-05
Terminated: 2015-05-19
Recalling firm: Depuy Orthopaedics Inc.
Product: SMARTSET GHV Gentamicin Bone Cement. A self-curing, radiopaque, polymethyl methacrylate based cement containing antibiotic. It is used for securing a metal or polymeric prosthesis to living bone in arthroplasty procedures. The bone cement has no intrinsic adhesive properties but relies instead on close mechanical interlock between the irregular bone surface and the prosthesis.
Product code: MBB Bone Cement, Antibiotic
Reason for recall: One lot of SMARTSET GHV Gentamicin Bone Cement is partially agglomerated . This may result in surgical delays while a replacement package of cement is retrieved and mixed.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: DePuy Orthopaedics, Inc. sent an Urgent Information - Recall Notice dated February 6, 2015, to all affected consignees for a voluntary recall of one lot of SMARTSET GHV Gentamicin Bone Cement because the affected cement is partially agglomerated (clumped together). Consignees were instructed to discontinue use of the affected lot of bone cement immediately and destroy according to the consignees hazardous materials protocol or return if Certified Dangerous Goods Shipper, holding an International Air Transport Association (IATA) certification. Customers were instructed to call 574-371-4917 (M-F; 8 am 5 pm EST). For questions regarding this recall call 574-371-4577.
Quantity in commerce: 1267
Distribution: Nationwide Distribution including CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MS, MT, NC, NV, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WV.
Product codes and lots: Cat. No. 545035500, Lot No. 7915797

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1246-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1246-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-11	2015-03-05

Product code MBB

K033563Class IISmartset Ghv Gentamicin Bone CementDePuy Orthopaedics, Inc. / cleared 2004-02-05

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)