Mallet, Surgical, General & Plastic Surgery
General, Plastic Surgery · 21 CFR 878.4800
Recent MDR events
17 adverse event reports on file
- V. MUELLERJun 5, 2025MalfunctionSteris Corporation1527821-2025-00008
- ACCLAIM MALLETJan 11, 2023MalfunctionDepuy Orthopaedics Inc Us1818910-2023-01007
- SLOTTED MALLETMay 7, 2022MalfunctionDepuy Orthopaedics Inc Us1818910-2022-08401
- SLOTTED MALLETDec 11, 2020MalfunctionDepuy Orthopaedics Inc Us1818910-2020-26809
- SLOTTED MALLETSep 22, 2020MalfunctionDepuy Orthopaedics Inc Us1818910-2020-20648
- SLOTTED MALLETJun 18, 2020MalfunctionDepuy Orthopaedics Inc Us1818910-2020-14105
- MILTEX MALLET 11 16OZNov 16, 2015MalfunctionIntegra York, Pa Inc.2523190-2015-00121
- ORTHOPEDIC 2POUND/1POUND MALLETOct 28, 2013MalfunctionKmedic Gmbh, Pilling Weck, Teleflex Medical3005236665-2013-00010
- ORTHOPEDIC 2POUND/1POUND MALLETOct 21, 2013MalfunctionKmedic Gmbh, Pilling Weck, Teleflex Medical Germany3005236665-2013-00007
- ORTHOPEDIC 2POUND/1POUND MALLETOct 21, 2013MalfunctionKmedic Gmbh, Pilling Weck, Teleflex Medical Germany3005236665-2013-00008
Event type breakdown
Recalls
2 recall events for this product code
- Signal Medical CorporationTerminatedApr 17, 2017
Soft Face "No Bounce" Mallet
Potential for poly tip of the mallet to come off during use. Potential for foreign material in the surgical field or delay in surgery. Reminder for customers that the poly tip must be removed for cleaning and sterilization to assure proper cleaning and sterilization of the entire mallet.
Z-1834-2017 · View FDA record ↗ - Smith & Nephew, Inc.TerminatedUnknown
smith&nephew PROFIX Mallet, 750 GRAMS, REF 71512452 - Product Usage: The PROFIX Mallet is a reusable surgical instrument used to tap instruments or implants dur
There is a a potential failure mode associated with the use of the mallet, wherein the poly tip of the mallet may become loose and/or come off during use. If the potential failure mode occurs, particles generated in the poly thread potentially could enter the surgical field or a delay in surgery could occur if the tip disengages during the use of the mallet.
Z-0696-2020 · View FDA record ↗
Registered firms
176 firms currently registered for this product code
Pfau Medizinische Instrumente Gmbh
WANFRIED Hesse, DE
Boss Instruments, Ltd.
Gordonsville, VA, US
Industrias Apson S.a De C.v
AGUA PRIETA Sonora, MX
Wexler Surgical, Inc.
HOUSTON, TX, US
Mian Shahid Corp.
MUZAFFAR PUR, SIALKOT Punjab, PK
Hgr Instrumente Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Aspen Surgical Products, Inc.
Caledonia, MI, US
Platts And Nisbett Ltd.
Sheffield, GB
Atria Co.
Seoul, KR
G. Hipp & Sohn Gmbh
NEUHAUSEN Baden-Wurttemberg, DE
Medcave Private Limited
Sialkot Punjab, PK
Depuy Orthopaedics, Inc.
WARSAW, IN, US
Integra Microfrance Sas
SAINT AUBIN LE MONIAL Auvergne-Rhone-Alpes, FR
Hexamed Pvt Ltd
Sialkot Punjab, PK
Fischer Surgical Inc.
Imperial, MO, US
Rudolf Storz Gmbh
EMMINGEN Baden-Wurttemberg, DE
Novo Surgical, Inc.
Westmont, IL, US
Wildmedical Gmbh
Tuttlingen Baden-Wurttemberg, DE
Aurora Surgical, Llc
St Petersburg, FL, US
Dimeda Instrumente Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Bailey Instruments Ltd
Manchester, GB
Qsa Surgical (pvt) Ltd.
SIALKOT Punjab, PK
Bausch & Lomb Incorporated
Manchester, MO, US
Aesculap, Inc.
CENTER VALLEY, PA, US
Aesculap Ag
TUTTLINGEN, DONAU Baden-Wurttemberg, DE
510(k) clearances
3 clearances for this product code