Knife, Orthopedic
Orthopedic · 21 CFR 888.4540
Recent MDR events
12 adverse event reports on file
- CONMEDJul 25, 2024MalfunctionConmed Largo1017294-2024-00087
- 4.5MM X 150MM LIBERATOR KNIFEMay 3, 2023InjuryConmed Largo1017294-2023-00039
- 4.5MM-15MM LIBERATOR KNIFEFeb 7, 2019MalfunctionConmed Corporation1017294-2019-00008
- MEDTRONICAug 27, 2018MalfunctionMedtronic Sofamor Danek, Inc7816314
- UNKNOWNSep 21, 2016MalfunctionK2m, Inc.3004774118-2016-00077
- KNIFE HANDLEAug 17, 2016MalfunctionK2m, Inc.5881795
- RASP LIBERATOR KNIFE II, 4.75 X 149MMDec 3, 2015Conmed Linvatec1017294-2015-00077
- SEGWAY ENDOSCOPIC SYSTEMMay 1, 2015MalfunctionSegway Orthopaedics, Inc.3010054483-2014-00001
- *Jun 17, 2014MalfunctionSegway Orthopaedics3943337
- DISPOSABLE BANANA BLADEMay 3, 2013InjuryConmed Linvatec1017294-2013-00016
Event type breakdown
Recalls
3 recall events for this product code
- Beaver Visitec International, Inc.Open, ClassifiedNov 8, 2022
Beaver Arthro-Lok Pointed Tip Curve L 4mm Blade-an orthopedic blade, which may be used in various types of orthopedic surgery (i.e. foot, ankle, hand, knee, hip
Incorrect configuration of the blades in the package. The blades curve to the right instead of curving to the left. If used may cause cause unintended tissue damage during the procedure or if noticed prior to use may cause a delay in surgery
Z-0197-2023 · View FDA record ↗ - Becton Dickinson and CompanyTerminatedMay 21, 2010
BD Beaver Arthro-Lok Pointed Tip 4mm Blade, REF 376780. Becton Dickinson and Company, Waltham, MA 02454.
Mislabeled: Arthro-Lok Pointed Tip 4mm Blade curving right instead of left.
Z-1638-2010 · View FDA record ↗ - Stryker Howmedica Osteonics Corp.TerminatedDec 15, 2009
Stryker Orthopaedics Sterile Knee Instrument, Patella Cutter;
Disposable Patella Cutters - 30 mm (catalog number 8000-0030, lot V31257001) were packaged and labeled as 33 mm Disposable Patella Cutters (catalog number 8000-0033, lot V31257001 and vice versa.
Z-0529-2010 · View FDA record ↗
Registered firms
120 firms currently registered for this product code
Bandex Industrial Corp.
Zhuhai City Guangdong, CN
Pro-med Instrumente Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Pacific Instruments Inc.
Honolulu, HI, US
Depuy Orthopaedics
BRIDGEWATER, MA, US
Oertel Medical Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Qsa Surgical (pvt) Ltd.
SIALKOT Punjab, PK
Rudolf Storz Gmbh
EMMINGEN Baden-Wurttemberg, DE
Med Saver, Inc.
PHOENIXVILLE, PA, US
Rafael Medical Devices, Llc
Newark, NJ, US
Dimeda Instrumente Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Dufner Instrumente Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Nexus Cmf
Salt Lake City, UT, US
Zimmer Trabecular Metal Technology, Inc.
Parsippany, NJ, US
Teleflex Llc (nadc)
Olive Branch, MS, US
Sklar Corporation - Warehouse
Salisbury, MD, US
Medline Renewal
Redmond, OR, US
Hafner Chirurgische Instrumente
BALGHEIM Baden-Wurttemberg, DE
Heuer International (a Division Of Gst Corporation Limited)
NOIDA Uttar Pradesh, IN
Microport Orthopedics Global Supply Center Limited
Shanghai, CN
Sterigenics Us, Llc
Lewis Center, OH, US
Isomedix Operations Inc.
CHESTER, NY, US
Medtronic Sofamor Danek Usa, Inc.
Memphis, TN, US
Warsaw Orthopedic, Inc.
WARSAW, IN, US
Aesculap Ag
TUTTLINGEN, DONAU Baden-Wurttemberg, DE
Linvatec Corporation
LARGO, FL, US
510(k) clearances
9 clearances for this product code
- Associated Medical Products Co.Feb 22, 1994
K930507 · CUSTOM ORTHOPAEDIC TRAYS (PACKS)
- Acufex Microsurgical, Inc.Jan 26, 1994
K933921 · ACUFLEX DISPOSABLE KNIVES
- Karlin Technology, Inc.Sep 22, 1988
K882525 · SPINAL MICROKNIFE
- Arthropedics, Inc.Nov 2, 1987
K873713 · TRIANGULAR KNIFE, DISPOSABLE #TM-1611
- Arthropedics, Inc.Nov 2, 1987
K873714 · BANANA KNIFE, DISPOSABLE #TM-1612
- Arthropedics, Inc.Nov 2, 1987
K873711 · RETROGRADE KNIFE, DISPOSABLE #TM-1613
- Arthropedics, Inc.Oct 15, 1987
K873712 · STANDARD KNIFE, DISPOSABLE #TM-1610
- Medtech Industries, Inc.Aug 14, 1984
K842820 · ARTHROSCOPY KNIVES