Devices

Device Recall Stryker

  • Model / Serial
    Catalog No. 6541-4-808 Lot Nos.: SB1K14, SB1K14A, SB1K14A1, SB1K14P, SB1K15, SB1K15A, SB1K15A1, SB1K15A2, SB1M25, SB1M25A, SB1M25A1, SB1M25A2, SB1M25A2X1, SB1N02, SB1N02A, SB1N02A1, SB1N02A2, SB1N02A3, SB1N02X1, SB1T05, SB1T05A, SB1T05A1, SB1T05AX1, SB1T05AX2, SB1T05KSB1V01, SB1V01K, SB1V01L, SB1V01X1, SB1V01X2, SB1V01X3, SB1W14, SB1W14K, SB1W14X1, SB2T19, SB2T19A, SB2T19D, SB2T19DX1, SB2T19DX2, SB2T19J, SB2T19K, SB2T19KX1, SB2T19KX2, SBT19X3, SB2V87, SB2V87A, SB2V87J, SB2V87JX1, SB2V87K, SB2V87X, SB2V87X1, SB2W23, SB2W23G, SB2W23X, SB2W23X1, SB3A20, SB3A20A, SB3A21, SB3A21D, SB3A21M, SB3A21X, SB3A22, SB3A22A1, SB3A22X1, SB3A55, SB3A55A, SB3A55A2, SB3A55AX1, SB3A55M, SB3A55X1, SB3H25, SB3H25D, SB3H25G, SB3H25X1, SB3H26, SB3H26D, SB3H26DX1, SB3H26X2, SB3K09, SB3K09X1, SB3K10, SB3K10L, SB3K10M, SB3K10MX1, SB3K10X1, SB3L19, SB3L19D, SB3L19K, SB3L19L, SB3L19P, SB3L19P1, SB3L20, SB3L20K, SB3L45, SB3L45A, SB3L45A1, SB3L45A2, SB3L45D, SB3L45DX1, SB3L45L, SB3L45T, SB3M17, SB3M17A, SB3M17K, SB3M17M, SB3M18, SB3M18A, SB3M18AX1, SB3M18D, SB3M18M, SB3M18R, SB3M19, SB3M19A, SB3M19A1, SB3M19S, SB3M19T, SB3M19W, SB3N46, SB3N46D, SB3N46P, SB3N46X1, SB4C12, SB4C12X1, SB4C37, SB4C37X1, SB4C38, SB4C38A, SB4C38D, SB4E18, SB4E181, SB4E181X1, SB4E18A, SB4E18D, SB4E18T, SB4H79, SB4H79A, SB4H79M, SB4L05, SB4L05A, SB4N17, SB4N17E, SB4N17M, SB4N17M1, SB4N18, SB4N18A, SB4N18A1, SB4N18D, SB4N18M, SB4N18T, SB4S01, SB4S01D, SB4S01J, SB4V07, SB4V07L, SB4V07M, SB4V07MM, SB5A02, SB5A02A, SB5A02A1, SB5A55
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US Nationwide
  • Product Description
    Stryker Orthopaedics Modular Handle Triathlon Instruments, Non-Sterile, REF 6541-4-808, Lot 123, NDC M546654148080S || Product Usage: || Is a reusable instrument that is part of the Triathlon Primary total knee arthroplasty (TKA) system as well as the Triathlon Partial Knee Replacement (PKR) system. The use of the handles in Primary TKA is optional and may be used to: (1) Assist in stabilizing the Triathlon Femoral Sizer, (2) Aid in stabilization during use and removal of the Triathlon 4:1 Cutting Block and (3) Aid in assembly of the Anterior MIS Distal Resection Guide to the Anterior Skim Cut Guide. Per the Triathlon PKR surgical protocol, the handle is required for a PKR surgery and is used to: (1) Assemble and disassemble the Femoral Trial Drill Guide into the Femoral Trial and (2) Remove the Peg Trial from the Femoral Trial.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.
  • 1 Event

Manufacturer

Stryker Howmedica Osteonics Corp.
  • Manufacturer Address
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2006
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA

499 devices with a similar name

Learn more about the data here

Device Recall Stryker Aria Inserter
  • Model / Serial
    Catalog #IS3021ARI, Lot #'s 20774, 20798, 20805 and 21990
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including OR, AZ, TN, MA, MD, GA, FL, NY, IA, IN, TX, MI, PA, UT, CA, MN, MO, OH, KS, OK, MT, FL, AL, CO, TN, and WI and Internationally to Australia.
  • Product Description
    Specialty Aria Inserter, REF IS3021ARI, Non-Sterile, || This instrument is part of the Aria product brand. It is used for Implant insertion into the disc space. The Aria Inserter PEEK Spacer System offers implants that are interbody fusion devices intended for use as an aid in spinal fixation. These hollow implants are offered in a variety of lengths, heights, and lordotic angles designed to adapt to different patient anatomies. They have serrations on the superior and inferior surfaces designed for multidirectional fixation, ergonomically shaped anterior edges, and flat posterior edges. This device does not sustain or support life.
  • Manufacturer
    Stryker Spine
Device Recall Stryker
  • Model / Serial
    Catalog #1806-1406S - Lot #'s K019A3C, K031467, K032811, K032812, K06AAA8, K07F95F and K083672, expiry date 3/31/2019 and Catalog #1806-1407S - Lot #'s K031468, K03E8AD and K074529, expiry date 3/31/2019
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Nationwide Distribution in the states of CA, FL, IN, MD, NC, NH, NY, OH, PA and WI.
  • Product Description
    Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-1406S, SPI 08-11 and b) REF 1806-1407S, SPI 08-13. || Product Usage: || The T2 Tibial Nailing system is intended to provide temporary stabilization of various types of fractures, malunion and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compressed locked. The system is indicated for long bone fracture fixation, specifically tibial fracture fixation. The sleeves are intended to ease nail insertion and to protect the condyle surfaces during nail insertion.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.
Device Recall Stryker stretcher
  • Model / Serial
    Serial numbers 0508083666, 0509069531, 0509069532, 0509069533, 0509069534, 0509069535, 0509069542, 0509069564, 0509069565, 0509069566, 0509069567, 0509069568, 0509069569, 0509069588, 0509069589, 0509069590, 0509069591, 0509069662, 0509069663, 0509069664, 0509069665, 0509069693, 0509069694, 0509069695, 0509069696, 0509069697, 0509069698, 0509069699, 0509069700, 0509069701, 0509069770, 0509069771, 0509069772, 0509069773, 0509069774, 0509069775, 0509069776, 0509069777, 0509069778, 0509069795, 0509069796, 0509069806, 0509069816, 0509069817, 0509069818, 0509069819, 0509069832, 0509069835, 0509069836, 0509069837, 0509069838, 0509069839, 0509069840, 0509069841, 0509069848, 0509069849, 0509069873, 0509069874, 0509069875, 0509069876, 0509069877, 0510071024, 0510071025,  0510071026, 0510071032, 0510071033, 0510071034, 0510071035, 0510071036, 0510071037, 0510071038, 0510071039, 0510071040, 0510071041, 0510071042, 0510071043, 0510071154, 0510071155, 0510071156, 0510071157, 0510071158, 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  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide: USA, Latin America, Mexico and Spain.
  • Product Description
    Stryker Medical -Wheeled Electric Stretcher, Model 1550 (with and without scales)
  • Manufacturer
    Stryker Medical Div. of Stryker Corporation
Device Recall Stryker Radius Locking Caps
  • Model / Serial
    Catalog # 486610000 Lot code: 06C516, 06C358, 06C515, 06C581, 06C447, 06C579, 06C446, 06C467, 06A858 and 06C357
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide- USA: Distributed to Stryker Branches/Agencies in MA, NY, NC. IN, MI, OK, TX,CO, AZ, WI, KS, CA, OR and hospitals in NC IN, MI, MO. KS, TZ, AZ, CA. OR and WA and Country of Italy
  • Product Description
    Stryker Radius Locking Caps, Catalog Number: 486610000, Manufactured by Stryker Spine SAS Z.I. Marticot - 33610 Cestas France.,Distributed by Howmedica Osteonics Corp. 325 Corporate Drive, Mahway, NJ 07430
  • Manufacturer
    Stryker Spine
Device Recall Stryker stretcher, Model 1009.
  • Model / Serial
    All stretchers with serial numbers beginning with 0309 through 0505.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide-USA, Argentina, Australia, Brazil, Canada, Chile, China, Dubai, France, India, Italy, Japan, Germany, Greece, Hong Kong, Korea, Latin America, Malaysia, Mexico, Netherlands, Poland, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, and United Kingdom.
  • Product Description
    Stryker Advantage Series Emergency Care wheeled stretcher, Model 1009, Stryker Medical, Portage, MI 49002
  • Manufacturer
    Stryker Medical Div. of Stryker Corporation
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