SmartSet¿ Endurance GMV — Class II medical device recall Z-0064-2014
Terminated recall by DePuy Orthopaedics, Inc., reported 2013-10-30, distributed in PR. The SmartSet¿ GMV Endurance Gentamicin Bone Cement, product ref: number 3105-040 is intended for use in indica
| Recall number | Z-0064-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DePuy Orthopaedics, Inc., Warsaw, IN, United States |
| Recall initiated | 2013-09-16 |
| Classified | 2013-10-23 |
| Reported by FDA | 2013-10-30 |
| Terminated | 2015-02-24 |
| Distributed | PR |
| Quantity | 16,040 units |
| Lot numbers | 1866567, 1890991, 1927220, 1933603, 1985488, 2047388, 2064474, 2332458, 2354798, 2374539, 2492886, 2521804, 2585596, 2589374, 2589379, 2610503, 2610505, 2641279, 2803352, 2839097, 2844909, 2866892, 2888115, 2889319, 2981608, 2991395, 3011228, 3042105, 3062608, 3078622, 3106436, 3115022, 3134757, 3166736, 3175434, 3205074, 3223183, 3236354, 3249497, 3249526 and 21 more |
| Model numbers | 3105-040 |
Product
SmartSet¿ Endurance GMV, Gentamicin, REF 3105-040, Medium Viscosity Antibiotic Bone Cement, Sterile. SmartSet GMV Endurance Gentamicin, bone cements are self-curing, radiopaque, polymethyl methacrylate based cements, containing antibiotic, used for securing a metal or polymeric prosthesis to living bone in arthroplasty procedures where infection by gentamicin-sensitive organisms is a potential risk.
Reason for recall
The SmartSet¿ GMV Endurance Gentamicin Bone Cement, product ref: number 3105-040 is intended for use in indications that have not been cleared by the US FDA. The intended use stated in the IFU for the SmartSet¿ GMV Endurance Gentamicin Bone Cement is for the fixation of prostheses to living bone in arthroplasty procedures of joints in which infection by gentamicin-sensitive organisms is a potentia
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-0064-2014. 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.