Z-1246-2015 Class II Terminated
FDA device recall Z-1246-2015 was initiated by DePuy Orthopaedics, Inc. on Feb 11, 2015 and is designated Class II. 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. The recall status is terminated (terminated May 19, 2015). Affected quantity: 1267.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 11, 2015
- Initiation Date
- Feb 11, 2015
- Termination Date
- May 19, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1267
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.
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.
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.
Code Information
Cat. No. 545035500, Lot No. 7915797
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1246-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026