Home › Device types › MBB
Bone Cement, Antibiotic
FDA product code MBB · Class 2 · Orthopedic
248
Registered devices
3,737
Adverse events
7
Recalls
19
510(k) clearances
Devices with this code
PROSTALAC — DEPUY ORTHOPAEDICS, INC.Remedy Spacer — OSTEOREMEDIES, LLCRemedy Spacer — OSTEOREMEDIES, LLCSMARTSET — DEPUY (IRELAND)PALACOS® — Heraeus Medical GmbHSpaceFlex Hip — G21 SRLSURESPACE — Ortho Development CorporationSTAGEONE — Biomet Orthopedics, LLCRemedy Spacer — OSTEOREMEDIES, LLCRemedy Spacer — OSTEOREMEDIES, LLCSpaceFlex Shoulder — G21 SRLRemedy Spacer — OSTEOREMEDIES, LLCSTAGEONE — Biomet Orthopedics, LLCPALACOS® — Heraeus Medical GmbHRemedy Spacer — OSTEOREMEDIES, LLCPROSTALAC — DEPUY ORTHOPAEDICS, INC.CeMend Shoulder Spacer Mold — G21 SRLCemex Genta HV — TECRES SPASTAGEONE — Biomet Orthopedics, LLCRemedy Spacer — OSTEOREMEDIES, LLCPALACOS® — Heraeus Medical GmbHRemedy Spacer — OSTEOREMEDIES, LLCStageOne Select — Biomet Orthopedics, LLCStageOne Select — Biomet Orthopedics, LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-20 | Heraeus Medical GmbH (Dental Division) | Potential for monomer liquid leakage. |
| 2026-08-20 | Heraeus Medical GmbH (Dental Division) | Potential for monomer liquid leakage. |
| 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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