Drills, Burrs, Trephines & Accessories (compound, Powered)
Neurology · 21 CFR 882.4305
Recent MDR events
2,726 adverse event reports on file
- CODMAN DISPOS PERFORATORJul 27, 2026OtherIntegra Lifesciences Mansfield3014334038-2026-00059
- CODMAN DISPOS PERFORATORJul 1, 2026MalfunctionIntegra Lifesciences Mansfield3014334038-2026-00055
- ACRA-CUT INCJun 23, 2026MalfunctionAcra-cut Inc.1220724-2026-05052
- CODMAN DISPOS PERFORATORJun 18, 2026MalfunctionIntegra Lifesciences Mansfield3014334038-2026-00053
- CODMAN DISPOS PERFORATORJun 5, 2026InjuryIntegra Lifesciences Mansfield3014334038-2026-00040
- ZYPHR DISP CRAN PERF LRG 14/11Jun 3, 2026InjuryStryker Instruments-a Division Of Stryker Corp3015967359-2026-00419
- ZYPHR DISP CRAN PERF LRG 14/11Jun 3, 2026InjuryStryker Instruments-a Division Of Stryker Corp3015967359-2026-00421
- CODMAN DISPOS PERFORATORMay 29, 2026MalfunctionIntegra Lifesciences Mansfield3014334038-2026-00037
- CODMAN DISPOS PERFORATORMay 22, 2026MalfunctionIntegra Lifesciences Mansfield3014334038-2026-00036
- ZYPHR DISP CRAN PERF LRG 14/11May 20, 2026InjuryStryker Instruments-a Division Of Stryker Corp3015967359-2026-00357
Event type breakdown
Recalls
6 recall events for this product code
- Integra LifeSciences Corp. (NeuroSciences)Open, ClassifiedNov 3, 2025
CODMAN Disposable Perforator 11mm. Cranial Perforator.
Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an abundance of caution.
Z-0373-2026 · View FDA record ↗ - Integra LifeSciences Corp. (NeuroSciences)Open, ClassifiedNov 3, 2025
CODMAN Disposable Perforator 9mm. Cranial Perforator.
Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an abundance of caution.
Z-0374-2026 · View FDA record ↗ - Integra LifeSciences Corp. (NeuroSciences)Open, ClassifiedMay 6, 2025
CODMAN Disposable Perforator, 14mm. Cranial perforator.
Inadequate weld that can potentially cause the product to disassemble.
Z-1716-2025 · View FDA record ↗ - Integra LifeSciences Corp. (NeuroSciences)Open, ClassifiedMay 6, 2025
CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial perforator kit.
Inadequate weld that can potentially cause the product to disassemble.
Z-1717-2025 · View FDA record ↗ - Stryker Instruments Div. of Stryker CorporationTerminatedNov 6, 2020
Stryker Zyphr Disposable Cranial Perforator, Large 14/11 mm- is a sterile, single use cutting accessory intended for cutting an 11 mm diameter access hole throu
Potential for the inner bit to contain a crack, that may or may not be visible, which may lead to metal fragments entering the surgical site and/or delayed disengagment during use.
Z-0431-2021 · View FDA record ↗ - Biomet Microfixation, Inc.TerminatedJan 11, 2012
Box labeled in part, "REF: 72-1000***IQ SYSTEM IQ INTELLIGENT DRIVER 16.51CM (6.5")(L) RABALON, STAINLESS STEEL, GOLD PLATED***NON-STERILE PRODUCT*** MADE IN TH
Biomet Microfixation, Inc., Jacksonville, FL, recalled their IQ Intelligent Device, 72-1000 due to failure of the front bit sensor to detect the correct bit that is installed. When a screw is inserted with the device in drill mode, it is possible for the screw or bone to strip.
Z-0447-2012 · View FDA record ↗
Registered firms
40 firms currently registered for this product code
Integra Lifesciences Production Corporation
Mansfield, MA, US
Cbr Enterprise Limited
Hong Kong, HK
Integra Lifesciences Corporation
Princeton, NJ, US
Stryker Instruments
Portage, MI, US
Stryker Ireland Ltd., Instruments Division
CARRIGTWOHILL, CO.CORK Munster, IE
Bgs Beta-gamma-service Gmbh & Co Kg
Wiehl North Rhine-Westphalia, DE
Worldwide Supplies Limited
Hong Kong, HK
Gammatom S.r.l.
GUANZATE (CO) Como, IT
Adeor Medical Ag
Valley Bavaria, DE
Sterigenics Us Llc
Charlotte, NC, US
Synthes Gmbh
Zuchwil Solothurn, CH
Ad Supply Group Limited
London London, City of, GB
Isomedix Operations, Inc.
Temecula, CA, US
Isomedix Operations Inc.
Northborough, MA, US
Emd Endoszkop Muszer Gyarto Es Kereskedelmi Kft.
Debrecen Hajdu-Bihar, HU
Mainline Medical Dental Supply
North York Ontario, CA
Sanicure Bv
SCHIPHOL Noord-Holland, NL
Synergy Health Westport Ltd
Westport Mayo, IE
Acra Cut, Inc.
ACTON, MA, US
Synergy Health Sterilisation Uk Ltd
West Yorkshire Bradford, GB
510(k) clearances
18 clearances for this product code
- Evonos GmbH & Co. KGMar 6, 2024
K231403 · evoDrill Cranial Perforator
- Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft.Jun 20, 2022
K213228 · NeuroLine Disposable Cranial Perforator with Hudson end
- Integra Lifesciences Corp.Jan 20, 2019
K183581 · Codman Disposable Perforators
- Micromar Ind. Com. , Ltd.Mar 16, 2015
K141455 · EASYDRILL AUTOSTOP CRANIAL PERFORATOR
- Adeor Medical Technologies GmbHJul 17, 2012
K121253 · MERIDIAN CRANIAL PERFORATOR
- Stryker Ireland Ltd., Instruments DivisionDec 29, 2008
K082010 · STRYKER DISPOSABLE CRANIAL PERFORATOR BIT
- The Anspach Effort, Inc.Dec 22, 2008
K082637 · CRANIAL PERFORATOR
- Codman & Shurtleff, Inc.Jan 4, 2008
K073336 · CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231