SMARTSET GHV Gentamicin Bone Cement — Class II medical device recall Z-1246-2015
Terminated recall by DePuy Orthopaedics, Inc., reported 2015-03-11, distributed nationwide. One lot of SMARTSET GHV Gentamicin Bone Cement is partially agglomerated . This may result in surgical delays
| Recall number | Z-1246-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DePuy Orthopaedics, Inc., Warsaw, IN, United States |
| Recall initiated | 2015-02-11 |
| Classified | 2015-03-05 |
| Reported by FDA | 2015-03-11 |
| Terminated | 2015-05-19 |
| Distributed | Nationwide (US) |
| Quantity | 1,267 |
| Lot numbers | 7915797 |
| Model numbers | 545035500 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1246-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.