—#133929

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.

FDA product code: MBB — Bone Cement, Antibiotic
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K033563
Affected lot / code info: Cat. No. 545035500, Lot No. 7915797

Why it was recalled

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 (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: DePuy Orthopaedics, Inc.
Address: 700 Orthopaedic Dr, Warsaw, Indiana 46582-3994

Distribution

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.

Timeline

Recall initiated: 2015-02-11
Posted by FDA: 2015-03-05
Terminated: 2015-05-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #133929. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.