Home › Device types › MBB
Bone Cement, Antibiotic
FDA product code MBB · Class 2 · Orthopedic
230
Registered devices
3,697
Adverse events
5
Recalls
19
510(k) clearances
Devices with this code
KASM — Ortho Development CorporationStageOne™ — Biomet Orthopedics, LLCSMARTSET — DEPUY (IRELAND)REFOBACIN® BONE CEMENT R — BIOMETSpaceFlex Knee — G21 SRLSTAGEONE SELECT — Biomet Orthopedics, LLCNA — DEPUY (IRELAND)StageOne™ — Biomet Orthopedics, LLCCeMend Shoulder Spacer Mold — G21 SRLSTAGEONE — Biomet Orthopedics, LLCStageOne Select — Biomet Orthopedics, LLCCeMend Shoulder Spacer — G21 SRLCeMend Shoulder Spacer — G21 SRLDJO SURGICAL — Encore Medical, L.P.CeMend Shoulder Spacer Mold — G21 SRLCeMend Shoulder Spacer Mold — G21 SRLSignature -x Cement — TEKNIMEDInterspace GV Hip Spacer 46 — TECRES SPACeMend Shoulder Spacer Mold — G21 SRLSpaceFlex Hip — G21 SRLStageOne™ — Biomet Orthopedics, LLCStageOne Select — Biomet Orthopedics, LLCSTAGEONE — Biomet Orthopedics, LLCCeMend Shoulder Spacer Mold — G21 SRL
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-10-21 | Howmedica Osteonics Corp. | Simplex HV With Gentamicin CE, 10 PACKS (P/N 6193-1-010) were distributed to customers who had ordered Simplex HV With Gentamicin in US, 10 PACKS (P/N 6195-1-0 |
| 2015-02-11 | DePuy Orthopaedics, Inc. | 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 |
| 2013-11-04 | Zimmer, Inc. | The patient label associated with the product may be incorrect in that the lot number on the patient label may be different than the lot number on the outer car |
| 2013-09-16 | DePuy Orthopaedics, Inc. | 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 |
| 2006-11-07 | Stryker Howmedica Osteonics Corp. | The expiration date on the external label is incorrect in that it does not identify the earliest expiration date of the subcomponents. The External label provid |
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