Punch, Surgical
General, Plastic Surgery · 21 CFR 878.4800
Recent MDR events
756 adverse event reports on file
- ATTUNEJun 30, 2026MalfunctionDepuy Ireland - 96166711818910-2026-11122
- METZENBAUM SCS 7 CVD MATTEJun 15, 2026MalfunctionIntegra Lifesciences Mansfield3014334038-2026-00048
- 40 DEG UP-BITING LAMINECTOMY PUNCH 4MM WIDTH/330MM LENGTHJun 10, 2026MalfunctionSynthes Gmbh8030965-2026-05772
- ATTUNEJun 9, 2026MalfunctionDepuy Ireland - 30155162661818910-2026-09900
- OSSIO PUNCHJun 4, 2026MalfunctionOssio Ltd.MW5188937
- RSP 4.0MM TAPERED TIP 6BOX STJun 1, 2026MalfunctionA&e Medical Corporation0002242056-2026-00007
- RSP 2.7MM TAPERED TIP 6BOX STMay 27, 2026MalfunctionA&e Medical Corporation0002242056-2026-00006
- ATTUNEMay 21, 2026MalfunctionDepuy Ireland - 96166711818910-2026-09083
- INTEGRA® MILTEX®May 15, 2026MalfunctionIntegra Lifesciences Production Corporation25183753
- 40 DEG UP-BITING LAMINECTOMY PUNCH 2MM WIDTH/330MM LENGTHFeb 24, 2026MalfunctionSynthes Gmbh8030965-2026-01861
Event type breakdown
Recalls
6 recall events for this product code
- DePuy Orthopaedics, Inc.TerminatedFeb 9, 2016
SIGMA HP MBT Non-Keel Punch Knee Instrument.
Increased punch height, causing a 0.063 in (1.6 mm) gap between the trial and the instrument. This may cause the surgeon to select an insert that is too thin. Surgical delay may result if the punch dislodges from the inserter and needs to be removed from the joint space. Insert Dislocation or Spin Out, or Poor Joint Mechanics may result, if not noted during surgery. May require revision surgery.
Z-0787-2016 · View FDA record ↗ - Clorox Healthcare Holdings, LLC (dba HealthLink)TerminatedJul 2, 2013
HealthLink***BIOPSY PUNCHES***
Due to lack of sterilization.
Z-1654-2013 · View FDA record ↗ - Clorox Healthcare Holdings, LLC (dba HealthLink)TerminatedJul 2, 2013
PSS Select medical products***Biopsy Punches***
Due to lack of sterilization.
Z-1655-2013 · View FDA record ↗ - Clorox Healthcare Holdings, LLC (dba HealthLink)TerminatedJul 2, 2013
ARGENT SURGICAL SYSTEMS***BIOPSY Punches***
Due to lack of sterilization.
Z-1656-2013 · View FDA record ↗ - Biomet, Inc.TerminatedSep 17, 2012
JUGGERKNOT INGUIDE PUNCH, 2.9MM.
Investigation found that the current design of the product allows the press-fit of the knob/shaft interface to be overcome by the impaction force of a mallet, causing the knob to potentially unfasten and slide down the shaft.
Z-2399-2012 · View FDA record ↗ - Alto Development CorpTerminatedUnknown
Surgical punch; sealed pouches packed in punch shelf box
Surgical punches are being recalled due to potential packaging damage which may have occurred during transportation resulting in loss of sterility.
Z-0813-2018 · View FDA record ↗
Registered firms
253 firms currently registered for this product code
Sfm Medical Devices Gmbh
Waechtersbach Hesse, DE
Paramount Surgimed Ltd.
BHIWADI Rajasthan, IN
Suban Instruments Germany Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Mizuho America, Inc.
Union City, CA, US
Hexamed Pvt Ltd
Sialkot Punjab, PK
Amplitude
Valence Drome, FR
Teleflex Llc (nadc)
Olive Branch, MS, US
Craftlink Medical Device Private Limited
Kolkata West Bengal, IN
Arthrex, Inc.
Ave Maria, FL, US
Cbr Enterprise Limited
Hong Kong, HK
Straits Orthopaedics (mfg) Sdn Bhd
Bandar Cassia Pulau Pinang, MY
Cole Instruments
Alpharetta, GA, US
Delasco, Llc
Plano, TX, US
Symmetry Medical Manufacturing Inc
CLAYPOOL, IN, US
Rumex International Co.
Tampa, FL, US
G. Hipp & Sohn Gmbh
NEUHAUSEN Baden-Wurttemberg, DE
Garish Apparels
Wazirabad Punjab, PK
Zapalign Llc
Fort Lauderdale, FL, US
Sinntech Medical (private) Limited
Sialkot Punjab, PK
Synthes (usa) Products Llc
West Chester, PA, US
Teleflex Medical De Mexico, S. De R.l. De C.v.
NUEVO LAREDO Tamaulipas, MX
Gebrueder Zepf
DUERBHEIM Baden-Wurttemberg, DE
Baeramed Instrumente Gmbh
SCHWENNINGEN Baden-Wurttemberg, DE
Trilliant Surgical Llc
Houston, TX, US
Sterigenics U.s., Llc
Salem, NJ, US
510(k) clearances
7 clearances for this product code
- Acuderm, Inc.Mar 24, 1994
K933516 · ACU-E PUNCH
- Kramer ConstMar 6, 1991
K904869 · ELLIPSE PUNCH
- Lipogen, Inc.Jun 28, 1990
K902636 · LIPOGEN RHEUMELISA DSDNA ASSAY
- Premier MedicalFeb 13, 1990
K896303 · BIOPSY PUNCH
- Med-Tool, Inc.Nov 23, 1987
K874356 · PIN PUNCH
- Med-Tool, Inc.Nov 23, 1987
K874357 · TAPERED PUNCH
- Med-Tool, Inc.Jul 23, 1987
K872388 · NAIL SET