Extractor
Orthopedic · 21 CFR 888.4540
Recent MDR events
3,487 adverse event reports on file
- PINNACLEJul 30, 2026MalfunctionDepuy Orthopaedics Inc Us1818910-2026-12998
- MODULAR HEAD BALL REMOVERJul 28, 2026MalfunctionDepuy Orthopaedics Inc Us1818910-2026-12856
- S-ROMJul 27, 2026MalfunctionDepuy Orthopaedics Inc Us1818910-2026-12526
- ESC PINNACLEJul 27, 2026MalfunctionDepuy Orthopaedics Inc Us1818910-2026-12525
- DRIVER EXTRACTORJul 27, 2026MalfunctionDepuy Orthopaedics Inc Us1818910-2026-12576
- UNK Extraction InstrumentJul 27, 2026MalfunctionDepuy Orthopaedics Inc Us1818910-2026-12577
- ESC PINNACLEJul 27, 2026MalfunctionDepuy Orthopaedics Inc Us1818910-2026-12741
- LPSJul 21, 2026MalfunctionDepuy Orthopaedics Inc Us1818910-2026-12366
- LPSJul 21, 2026MalfunctionDepuy Orthopaedics Inc Us1818910-2026-12364
- ESC PINNACLEJul 16, 2026MalfunctionDepuy Orthopaedics Inc Us1818910-2026-12105
Event type breakdown
Recalls
4 recall events for this product code
- Innomed, Inc.CompletedMay 1, 2024
INNOMED CUP REMOVAL STARTER INSTRUMENT, REF 520054, Hip cutter blade cup
54 MM finisher blade was inadvertently affixed to the shaft of the CupX handle in lieu of the 54 MM starter blade.
Z-1753-2024 · View FDA record ↗ - Encore Medical, LpTerminatedDec 28, 2010
CLP Instrumentation Removal Hook, distributed by DJO Surgical, manufactured by Encore Medical, Austin, TX.
Revision A and B CLP Extraction Hooks may fracture at the distal end, resulting in surgical delay.
Z-0828-2011 · View FDA record ↗ - Stryker Howmedica Osteonics Corp.TerminatedApr 27, 2010
Literature for Implant Extraction Set - Implant Extraction Guide Module One & Two.
Literature did not include the design change to a smaller cannulation diameter.
Z-1443-2010 · View FDA record ↗ - Synthes, Inc.TerminatedUnknown
Stem Extractor f/Guide Bar, Part number 03.401.072. Instrumentation for extraction and revision of Epoca shoulder implants.
There is a potential for the connection screw of the stem extractor to break.
Z-1514-2018 · View FDA record ↗
Registered firms
280 firms currently registered for this product code
Orthopediatrics, Corp
Warsaw, IN, US
Sontec Instruments, Inc.
CENTENNIAL, CO, US
S.s. White Technologies, Inc. / Dba Shukla Medical
St Petersburg, FL, US
Kapp Surgical Gmbh
DUERBHEIM Baden-Wurttemberg, DE
Tornier Inc.
Columbia City, IN, US
Arch Medical Solutions - Warsaw
Warsaw, IN, US
Kammerer Medical Systems Gmbh & Co. Kg
Stockach Baden-Wurttemberg, DE
Incipio Devices
Huntington, IN, US
Micropulse Inc
Columbia City, IN, US
Nginstruments, Inc Dba Avalign Cutting Instruments
Warsaw, IN, US
Zhejiang Biomet Medical Products Co., Ltd.
Jinhua Zhejiang, CN
Aegis Meditec, Inc.
Costa Mesa, CA, US
Parcus Medical , L.l.c.
Sarasota, FL, US
Nuvasive Specialized Orthopedics, Inc.
Audubon, PA, US
Syntec Scientific Corp.
CHANG HUA Changhua, TW
Microport Orthopedics Global Supply Center Limited
Shanghai, CN
Synthes Gmbh
Zuchwil Solothurn, CH
Mendell
Lakeville, MN, US
Ych Distripark Sdn Bhd
Prai Pulau Pinang, MY
Ych Distripark Sdn Bhd
Shah Alam Selangor, MY
Depuy Mitek, Inc.
RAYNHAM, MA, US
Ortoface Cosmeticos E Produtos Para Saude Ltda
Salto Sao Paulo, BR
Depuy (ireland)
CO. CORK Munster, IE
Five Star Manufacturing, Inc.
NEW BEDFORD, MA, US
Jabil Switzerland Manufacturing Gmbh (balsthal)
Balsthal Solothurn, CH
510(k) clearances
5 clearances for this product code
- Arthropedics, Inc.Nov 2, 1987
K873710 · MAGNETIC RETRIEVER, 1.7MM W/LUER FITTING TM-1350
- Warsaw Orthopedic, Inc.Mar 13, 1987
K870844 · SCHULTZ PROSTHESIS COMPONENT INSERTER EXTRACTOR
- Terray Manufacturing, Inc.Feb 26, 1987
K870083 · FERRAY EXTRACTOR
- The Anspach Effort, Inc.Jun 9, 1980
K801327 · THE EXTRACTOR I TM
- Richard'S Medical Equip., Inc.Feb 28, 1978
K780300 · HIP PLATE REMOVAL INSTRUMENT