Stryker Instruments Div. of Stryker Corporation
109 recalls on record · Latest: Jul 27, 2022
FDA Devices Moderate Jul 27, 2022
SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002-090. Used for counting, displaying, recording and locating the numb…
FDA Devices Moderate Jul 27, 2022
Triton Canister System (finished part numbers FG 12009, for 3L canisters, and FG 12019 for 2L canisters) Scanning Label (component part number 11032)…
FDA Devices Moderate May 6, 2020
Neptune E-SEP 165mm Blade Electrode, Catalog Number 0703-165-001 - Product Usage: The Neptune E-SEP is an Integrated Smoke Evacuation Pencil (pencil)…
FDA Devices Moderate Feb 12, 2020
SafeAir Telescopic Smoke Evacuation Pencil, Product No. 0703 046 004. The product is a Bovie pencil that is 75 inches long compressed, with a telesc…
FDA Devices Moderate Feb 12, 2020
Telescopic Uncoated (Push Button), Product No. SHK TSPL. The product is a Bovie pencil that is 75 inches long compressed, with a telescoping shaft. …
FDA Devices Moderate Dec 11, 2019
Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 2PRT(Dual Port) Quick Connect Connector, Product Number 5921-018-235 …
FDA Devices Moderate Dec 11, 2019
Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 1PRT(Single Port) Quick Connect Connector, Product Number 5921-018-13…
FDA Devices Moderate Oct 9, 2019
C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitori…
FDA Devices Moderate Oct 9, 2019
C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitori…
FDA Devices Moderate May 2, 2018
T4 Zipper Toga (S/M); Catalog Number: 0400-810-000 Sterile personal protection garment
FDA Devices Moderate May 2, 2018
T4 Zipper Toga, X-Large; Catalog number: 0400-850-000 Sterile personal protection garment
FDA Devices Moderate May 2, 2018
T5 Zipper Toga with Peel-Away Face Shield, (XL/T); Catalog number: 0400-850-100 Sterile personal protection garment
FDA Devices Moderate May 2, 2018
T4 Pullover Toga, L/XL; Catalog Number: 0400-720-000 Sterile personal protection garment
FDA Devices Moderate May 2, 2018
T4 Zipper Toga, Regular; Catalog number: 0400-830-000 Sterile personal protection garment
FDA Devices Moderate May 2, 2018
T4 Zipper Toga, (L/XL); Catalog Number: 0400-820-000 Sterile personal protection garment
FDA Devices Moderate May 2, 2018
T4 Pullover Toga, X-Large; Catalog Number: 0400-770-000 Sterile personal protection garment
FDA Devices Moderate May 2, 2018
T4 Pullover Toga, (S/M); Catalog Number: 0400-710-000 Sterile personal protection garment
FDA Devices Moderate May 2, 2018
T4 Pullover Toga, Regular ; Catalog Number: 0400-750-000 Sterile personal protection garment
FDA Devices Moderate Apr 4, 2018
Revolution CMS w/ Femoral Breakaway Nozzle & Med. Press., Product Number: 0606-573-000, UDI: (01)4546540912114 for orthopedic use.
FDA Devices Moderate Apr 4, 2018
Intramedullary Brush Standard O.D. 14 mm, Product Number: 6198-001-514, UDI: (01)4546540255853 for orthopedic use.
FDA Devices Moderate Apr 4, 2018
PCD Kit: Long 90, 13g Match-Ground w/ Bevel, Product Number: 0506-485-000, UDI: (01)4546540907035 for spinal orthopedic use.
FDA Devices Moderate Apr 4, 2018
11g Verteport Cement Cannula (18/pkg), Product Number: 0306-511-000, UDI: (01)7613252594307 for spinal orthopedic use.
FDA Devices Moderate Apr 4, 2018
10g/15mm (15/2) iVAS System Kit, Product Number: 0705-115-000, UDI: (01)7613252029830 for spinal orthopedic use.
FDA Devices Moderate Apr 4, 2018
1. 11g/10mm iVAS System Kit, Product Number: 0705-310-000, UDI: (01)7613252505983; 2. 11g/15mm iVAS System Kit, Product Number: 0705-315-000, UDI: (0…
FDA Devices Moderate Apr 4, 2018
Advanced Cement Mixing (ACM) Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press., Product Number: 0306-573-000, UDI: (01)4546540055415 for ortho…
FDA Devices Moderate Apr 4, 2018
1. Femoral Canal Pressurizer without Hub, Medium, Blue, Product Number: 0206-546-000, UDI: (01)4546540039552; 2. Femoral Canal Pressurizer without Hu…
FDA Devices Moderate Apr 4, 2018
Break-Away Femoral Nozzle, Product Number: 0206-512-000, UDI: (01)4546540039415 for orthopedic use.
FDA Devices Moderate Apr 4, 2018
1. AutoPlex System, Product Number: 0605-887-000, UDI: (01)4546540593108; 2. AutoPlex System: w/ VertaPlex HV, Product Number: 0607-687-000, UDI: (01…
FDA Devices Moderate Apr 4, 2018
The Stryker Thoracic Pedicle Feeler 6002-350-000 is a smart instrument for remote control of the navigation software and creation of a pathway into …
FDA Devices Moderate May 17, 2017
Stryker PROFESS Registration Kit. The Stryker PROFESS Registration Kit is a member of the Navigation portfolio and is used as an intraoperative guid…
FDA Devices Moderate May 3, 2017
Stryker SmartLife Large Aseptic Housing (7126-120-000)
FDA Devices Moderate Dec 28, 2016
8470-009-040 4.0MM Precision Round, 16CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseo…
FDA Devices Moderate Dec 28, 2016
8450-107-530 3.0MM Precision Match Head, 13CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove …
FDA Devices Moderate Dec 28, 2016
8470-009-030 3.0MM Precision Round, 16CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseo…
FDA Devices Moderate Dec 28, 2016
8450-010-040 4.0MM Round, 13CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseous mater…
FDA Devices Moderate Aug 31, 2016
120 V Neptune 3 Rover, Model Number: 0703-001-000
FDA Devices Moderate Jul 27, 2016
2.3MM Tapered Router, Product Number 5407-FA2-023 A router is a cutting accessory used in the following medical applications: Neuro; Spine; Ear, No…
FDA Devices Moderate Jul 20, 2016
6.0mm Round Fluted Bur, Super Long
FDA Devices Moderate Jun 15, 2016
Maestro Air Motor Pneumatic cranial drill motor. The Maestro Air Pneumatic System is a pneumatically operated surgical instrument system. The pne…
FDA Devices Moderate Apr 20, 2016
Spetzler Claw Tip, Universal - 5450-800-311 Spetzler Open Angle Micro Claw Tip, Universal - 5450-800-313 The Spetzler Claw" Tips are bone cutti…
FDA Devices Moderate Apr 20, 2016
SurgiCounter scanner, part of the SurgiCount Safety-Sponge System. Model numbers 0694-097-000 and 0694-097-001. Product Usage: The SurgiCoun…
FDA Devices Moderate Mar 9, 2016
(Stryker) AccuPlace Round Level Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.
FDA Devices Moderate Mar 9, 2016
(Stryker) AccuPlace Straight Level Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.
FDA Devices Moderate Mar 9, 2016
50000 (Inrad) AccuPlace Drace Stereotaxic Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.
FDA Devices Moderate Dec 23, 2015
Cournand Modified 2-PC 19G, 5.4cm or (Guidewire Introducer Needle) 20 units per case The Stryker Guidewire Introducer Needles are designed for the …
FDA Devices Moderate Sep 9, 2015
Neptune 2 Waste Management System Docking Station (120V and 230V), New and Refurbished Product Usage: The Stryker Docking Station (Docker) is a c…
FDA Devices Moderate Jul 29, 2015
Stryker SelectCore Variable Throw Biopsy Device, 14G, 10CM Product Usage: The Stryker SelectCore Variable Throw Biopsy Device is used in obtainin…
FDA Devices Moderate Jul 29, 2015
0702-001-350Q, Diverter Valve Assembly 0702-001-000, Neptune 2 Rover Ultra (120V) 0702-001-000R, Repair Neptune 2 Rover 0702-002-000, Neptune 2 R…
FDA Devices Moderate Jun 24, 2015
Navigation System II-Cart, 7700-100-000 with Articulated Arm Camera, 7700-103-001 and Articulated Arm Camera, 7700-103-001U Product Usage: The …
FDA Devices Moderate Jun 3, 2015