FDA Medical Device Recalls (openFDA)
DePuy Orthopaedics, Inc.: 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.
- Recall number
- Z-1246-2015
- 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.
- Status
- Terminated
- Initiated
- 2015-02-11
- Posted
- 2015-03-05
- Terminated
- 2015-05-19
- 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.
- 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
- 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.
- Lot, serial or model codes
- Cat. No. 545035500, Lot No. 7915797
- 510(k) numbers
- ["K033563"]
- PMA numbers
- not on file
- Product code
- MBB
- Firm FEI
- 1818910
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28