DePuy Orthopaedics, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1246-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: February 11, 2015

Date Posted: March 11, 2015

Recall Number: Z-1246-2015

Event ID: 70507

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.

Status: Terminated

Product Quantity: 1267

Code Information:

Cat. No. 545035500, Lot No. 7915797

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated