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Recall Observatory FDA recall evidence

Device 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.

Z-1246-2015

February 11, 2015

Class II

Product summary

Firm
DePuy Orthopaedics, Inc.
Event
Event 70507
Status
Terminated
Classification
Class II
Quantity
1267
Official record key
device-enforcement:Z-1246-2015

Official wording

Reason: 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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.