SMARTSET GHV Gentamicin Bone Cement. A self-curing… recallZ-1246-2015 · DePuy Orthopaedics, Inc. · initiated Feb 11, 2015
Class II Terminated All recalls posted in March 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from DePuy Orthopaedics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-1246-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Feb 11, 2015
- Posted by the FDA
- Mar 5, 2015
- Recalling firm
- DePuy Orthopaedics, Inc.
- Quantity
- 1267
- Product code
- MBB
- FDA submissions
- K033563
- 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.
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.
Code information (models, lots, serial numbers)
Cat. No. 545035500, Lot No. 7915797
Other devices under the same FDA submission
5 devices cleared under K033563 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- SMARTSET 5450-35-500Depuy (Ireland) · MIXER, CEMENT, FOR CLINICAL USE2 deaths965 reports
- SMARTSET 3092-040Depuy (Ireland) · BONE CEMENT, ANTIBIOTIC821 reports
- NA 5450-31-500Depuy (Ireland) · BONE CEMENT2 deaths168 reports
- NA 5450-32-500Depuy (Ireland) · BONE CEMENT1 death150 reports
- SMARTSET 3092-020Depuy (Ireland) · BONE CEMENT, ANTIBIOTIC23 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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