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  • Device 1211
  • Manufacturer 31827
  • Event 5885
  • Implant 4142
Total Knee Prosthesis ADVANCE
  • Model / Serial
    ADVANCE HA - KTTIHA10, KTTIHA11, KTTIHA20, KTTIHA21, KTTIHA30, KTTIHA31, KTTIHA40, KTTIHA41, || KTTIHA50, KTTIHA51 and KTTIHA60.
  • Product Classification
    Orthopedic Devices
  • Product Description
    Total WRIGHT knee systems are indicated for use in knee arthroplasty in patients with skeletal maturity and the following conditions; 1) non-inflammatory degenerative joint disease, including arthritis, traumatic arthritis or avascular necrosis; inflammatory degenerative disease, including rheumatoid arthritis; correction of deformities functions; review procedures when other treatments or devices have failed; and treatment of fractures that can not be controlled.
  • Manufacturer
    Microport Orthopedics Inc.
  • 1 Event
    • Safety Alert for Total Knee Prosthesis ADVANCE
Shoulder Implants
  • Model / Serial
  • Product Classification
    Orthopedic Devices
  • Product Description
    Indicated in cases of non-inflammatory joint degenerative disease such as osteoarthritis and avascular necrosis. Rheumatoid arthritis. Correction of functional deformity. Fractures of the proximal humerus. Clinical control problems difficult to administer that includes fist arthropathy.
  • Manufacturer
    Biomet Orthopedics Inc. || Zhejiang Biomet Medical Products Co., Ltd.
  • 1 Event
    • Safety Alert for Shoulder Implants
Zimmer Ardis Interbody Inserter
  • Model / Serial
    Model: Part Number 3256-01, Affected: All
  • Product Classification
    Orthopedic Devices
  • Manufacturer
    Zimmer Spine Inc
  • 1 Event
    • Recall of Zimmer Ardis Interbody Inserter
ardis inserter for ardis peek inserter for vertebral surgery
  • Model / Serial
  • Product Classification
    Orthopedic Devices
  • Product Description
    md
  • Manufacturer
    ZIMMER SPINE
  • 1 Event
    • Field Safety Notices about ardis inserter for ardis peek inserter for vertebral surgery
median oasys systems of spinal fixation
  • Model / Serial
  • Product Classification
    Orthopedic Devices
  • Product Description
    md
  • Manufacturer
    STRYKER SPINE
  • 1 Event
    • Field Safety Notices about median oasys systems of spinal fixation
offset impactor for acetabular cups standard instrumentation for hip prostheses
  • Model / Serial
  • Product Classification
    Orthopedic Devices
  • Product Description
    md
  • Manufacturer
    GREATBATCH MEDICAL
  • 1 Event
    • Field Safety Notices about offset impactor for acetabular cups standard instrumentation for hip prostheses
median occipital plaques oasyssystems of spinal fixation
  • Model / Serial
  • Product Classification
    Orthopedic Devices
  • Product Description
    md
  • Manufacturer
    STRYKER SPINE
  • 1 Event
    • Field Safety Notices about median occipital plaques oasyssystems of spinal fixation
profemur neck var / val 8dg long cobalt chromocomponent femoral neck.
  • Model / Serial
  • Product Classification
    Orthopedic Devices
  • Product Description
    md
  • Manufacturer
    MICROPORT ORTHOPEDICS
  • 1 Event
    • Field Safety Notices about profemur neck var / val 8dg long cobalt chromocomponent femoral neck.
advance has coated tibial bases for knee prosthesis.
  • Model / Serial
  • Product Classification
    Orthopedic Devices
  • Product Description
    md
  • Manufacturer
    MICROPORT ORTHOPEDICS
  • 1 Event
    • Field Safety Notices about advance has coated tibial bases for knee prosthesis.
M / L cones with femoral stems and modular necks Kinectiv
  • Model / Serial
  • Product Classification
    Orthopedic Devices
  • Product Description
    medical_device
  • Manufacturer
    ZIMMER INC.
  • 1 Event
    • Recall of M / L cones with femoral stems and modular necks Kinectiv
PROFEMUR VAR / VAL LONG CoCr Modular Collar
  • Model / Serial
  • Product Classification
    Orthopedic Devices
  • Product Description
    medical_device
  • Manufacturer
    MICROPORT ORTHOPEDICS
  • 1 Event
    • Recall of PROFEMUR VAR / VAL LONG CoCr Modular Collar
Ptg Advance Non-cemented Tibial Headplates
  • Model / Serial
  • Product Classification
    Orthopedic Devices
  • Product Description
    medical_device
  • Manufacturer
    Microport Orthopedics
  • 1 Event
    • Recall of Ptg Advance Non-cemented Tibial Headplates
Standard Offset Cup Impactor with POM-C Handle
  • Model / Serial
  • Product Classification
    Orthopedic Devices
  • Product Description
    medical_device
  • Manufacturer
    Greatbatch Medical
  • 1 Event
    • Recall of Standard Offset Cup Impactor with POM-C Handle
Inverted Shoulder Total Prosthesis Tray
  • Model / Serial
  • Product Classification
    Orthopedic Devices
  • Product Description
    medical_device
  • Manufacturer
    Zimmer Biomet
  • 1 Event
    • Recall of Inverted Shoulder Total Prosthesis Tray
Oasys Midline Spine Surgery Plates
  • Model / Serial
  • Product Classification
    Orthopedic Devices
  • Product Description
    medical_device
  • Manufacturer
    STRYKER
  • 1 Event
    • Recall of Oasys Midline Spine Surgery Plates
Device Recall NexGen Complete Knee Solution Monoblock Tibial Provisional/Drill Guide
  • Model / Serial
    Part number 00-5887-045-00 Lot number 62592928
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Distribution and the countries of Australia and Denmark.
  • Product Description
    NexGen Complete Knee Solution Monoblock Tibial Provisional / Drill Guide Tibial Size 5 Femoral Size Green / CH || Zimmer U.K. Ltd., SN3 4FP, UK || Zimmer Trabecular Metal Technology, Inc || 10 Pomeroy Road, Parsippany, NJ 07054 USA
  • Manufacturer
    Zimmer Trabecular Metal Technology, Inc.
  • 1 Event
    • Recall of Device Recall NexGen Complete Knee Solution Monoblock Tibial Provisional/Drill Guide
Device Recall ORTHOSENSOR KNEE BALANCER, VERASENSE KNEE SYSTEM
  • Model / Serial
    Model SYK-TRCR 02, Lot # 091914V11770, Serial #s: 411654008, 411585023, 411654007, 411585032, 411585014, 411654016, 411585017, 411654015, 411585030, 411654020, 411654004, 411654010, 411585007, 411585005, 411654011, 411585036, 411585035, 411654018, 411654012, 411585011, 411654014, 411654005, 411654001, 411585003.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of : IL, MI, NY, CA, VA and NV.
  • Product Description
    Verasense Knee System, Model SYK-TRCR 02. Intelligent disposable tibial insert that measures dynamic loads during orthopedic knee surgery.
  • Manufacturer
    Orthosensor, Inc.
  • 1 Event
    • Recall of Device Recall ORTHOSENSOR KNEE BALANCER, VERASENSE KNEE SYSTEM
Device Recall ATTUNE INTUITION
  • Model / Serial
    CATALOG NO. : 2544-01-017 LOT NUMBER: All Lots Barcode GTIN: 10603295423324
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-US (nationwide) except AK and RI, including PR and the countries of Chile, Canada, Australia, Austria, Belgium, France, Hong Kong, Ireland, India, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Thailand, United Arab Emirates (UAE), and United Kingdom (UK
  • Product Description
    The ATTUNE INTUITION Impaction Handle is a re-useable instrument utilized in knee replacement procedures. The instrument interfaces with several related ATTUNE instruments: keel punch, tibial tower, evaluation bullet, fixed bearing tibial impactor, rotating platform tibial impactor, and femoral impactor, for the purpose of impaction, extraction, and insertion applications at steps within the surgical procedure. Due to the frequency of its use, two impaction handles are supplied in each kit.
  • Manufacturer
    DePuy Orthopaedics, Inc.
  • 1 Event
    • Recall of Device Recall ATTUNE INTUITION
Device Recall Mandible Locking Plate (MLP) Bender / Cutter
  • Model / Serial
    Sold Lot Numbers: 4520830 4519339 4528112 4527510 4527509 4528678 4529517 4532428 4542201 4547106 4547107 4548231 4552202 4552203 4562899 4566835 4572774 4572775 4578754 4581035 4593516 4738938 4768238 4805320 4805321 4805622 4805623 4814351 4869678 4871808 4880493 4880495 4888588 4915212 4915213 4935249 4935250 4964319 4964324 4973229 5021231 5021232 5021233 5036650 5036651 5056855 5056154 5056856 5079563 5079564 5079565 5079538 5090675 5090677 5105352 5144695 5144697 5144696 5161969 5161970 5191074 5196260 5229584 5229586 5229585 5229587 5253009 5256476 5256477 5262049 5267000 5276395 5278583 5283776 5283780 5353853 5360628 5367534 5367535 5370545 5388335 5370546 5388336 5765950 5775823; Manufacturing Lot Number A7LA49 A7LA48 A7LA51 A7LA50 A7LA50 A7LA51 A7LA51 A7LA47 A7MA03 A7MA05 A7MA05 A7MA05 A7MA06 A7MA06 A7MA09 A7MA10 A7MA11 A7MA11 A7MA13 A7MA14 A7MA18 A7NA08 A7NA08 A7NA25 A7NA25 A7NA25 A7NA25 A7NA25 A7NA40 A7NA41 A7NA43 A7NA43 A7NA43 A7NA43 A7NA51 A7NA52 A7NA51 A7OA09 A7OA09 A7OA09 A7OA21 A7OA21 A7OA21 A7OA24 A7OA24 A7OA30 A7OA29 A7OA33 A7OA29 A7OA35 A7OA35 A7OA36 A7OA38 A7OA38 A7OA41 A7OA50 A7OA50 A7OA50 A7OA51 A7OA51 A7PA07 A7PA08 A7OA50 A7OA51 A7PA08 A7PA07 A7PA20 A7PA21 A7PA21 A7PA21 A7PA23 A7PA23 A7PA24 A7PA25 A7PA25 A7PA39 A7PA40 A7PA41 A7PA41 A7PA42 A7PA41 A7PA42 A7PA43 A7PA47 A7PA47
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US and Canada.
  • Product Description
    2.0 Mandible Locking Plate (MLP) Bender / Cutter (part number 329.143) || Intended to be used for bending and/or cutting Mandible Locking Plates.
  • Manufacturer
    Synthes, Inc.
  • 1 Event
    • Recall of Device Recall Mandible Locking Plate (MLP) Bender / Cutter
Device Recall POWEREASE(TM) Instruments Set Screw Breakoff Instrument
  • Model / Serial
    Lot # - CA14C107
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of : CA, KS, KY, NC, TX, WA, MI, OH, IA, PA, OR, MS, FL, NY, GA and AR.
  • Product Description
    POWEREASE Instruments Set Screw Breakoff Instrument, REF 2346010, Medtronic Sofamor Danek, USA, Inc. Spinal surgical instrumrent.
  • Manufacturer
    Medtronic Sofamor Danek USA Inc
  • 1 Event
    • Recall of Device Recall POWEREASE(TM) Instruments Set Screw Breakoff Instrument
Device Recall Fixed Tibial bearing ATTUNE INTUITION Impactor
  • Model / Serial
    CATALOG NO. : ATTUNE INTUITION Impactors  Fixed Tibial Bearing, (254401003)  Barcode GTIN Number:  Fixed Tibial Bearing, ......... 10603295130192   ALL LOTS
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) including P.R. except AK and RI; and Internationally to: Chile, Canada, Australia, Austria, Belgium, China, France, Ireland, India, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Thailand, United Arab Emirates (UAE), and United Kingdom (UK).
  • Product Description
    Fixed Tibial bearing ATTUNE INTUITION Impactor || The ATTUNE INTUITION Impactors are re-useable instruments utilized in knee replacement procedures. The three affected impactors are used at various times within the surgical flow, each impactor is used to impact and drive home its relevant mating part: Fixed Tibial bearing, (254401003) Rotating Tibial Platform, (254401004) and Femoral impactor, (254401006).
  • Manufacturer
    DePuy Orthopaedics, Inc.
  • 1 Event
    • Recall of Device Recall Fixed Tibial bearing ATTUNE INTUITION Impactor
Device Recall Rotating Tibial Platform ATTUNE INTUITION Impactor
  • Model / Serial
    CATALOG NO. : ATTUNE INTUITION Impactors  Rotating Tibial Platform, (254401004)  Barcode GTIN Number:  Rotating Tibial Platform, ......... 10603295130208  ALL LOTS
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) including P.R. except AK and RI; and Internationally to: Chile, Canada, Australia, Austria, Belgium, China, France, Ireland, India, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Thailand, United Arab Emirates (UAE), and United Kingdom (UK).
  • Product Description
    Rotating Tibial Platform ATTUNE INTUITION Impactor. || The ATTUNE INTUITION Impactors are re-useable instruments utilized in knee replacement procedures. The three affected impactors are used at various times within the surgical flow, each impactor is used to impact and drive home its relevant mating part: Fixed Tibial bearing, (254401003) Rotating Tibial Platform, (254401004) and Femoral impactor, (254401006).
  • Manufacturer
    DePuy Orthopaedics, Inc.
  • 1 Event
    • Recall of Device Recall Rotating Tibial Platform ATTUNE INTUITION Impactor
Device Recall Femoral Impactor ATTUNE INTUITION Impactor
  • Model / Serial
    CATALOG NO. : ATTUNE INTUITION Impactors  Femoral Impactor, (254401006)  Barcode GTIN Number:  Femoral Impactor, 10603295130222  ALL LOTS
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) including P.R. except AK and RI; and Internationally to: Chile, Canada, Australia, Austria, Belgium, China, France, Ireland, India, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Thailand, United Arab Emirates (UAE), and United Kingdom (UK).
  • Product Description
    Femoral Impactor ATTUNE INTUITION Impactor. || The ATTUNE INTUITION Impactors are re-useable instruments utilized in knee replacement procedures. The three affected impactors are used at various times within the surgical flow, each impactor is used to impact and drive home its relevant mating part: Fixed Tibial bearing, (254401003) Rotating Tibial Platform, (254401004) and Femoral impactor, (254401006).
  • Manufacturer
    DePuy Orthopaedics, Inc.
  • 1 Event
    • Recall of Device Recall Femoral Impactor ATTUNE INTUITION Impactor
Device Recall HP LCS IM Hole Locator instrument
  • Model / Serial
    CATALOG NO. : 9505-01-041 Barcode GTIN: 10603295224389 ALL LOTS
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) including states of: AZ, CA, CO, FL, GA, HI, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MT, NC, NV, NY, OH, PA, TN, TX, VA, WA, and WI; and countries of: Canada, Australia, Austria, Belgium, Czech Republic, France, Germany, India, Israel, Italy, Japan, Malaysia, Russia, South Africa, Switzerland, and United Kingdom.
  • Product Description
    I.M. Hole Locator Instrument. Orthopedic manual surgical instrument. || The IM Hole locator guides the IM drill during IM Hole preparation. The instrument is positioned between the condyles and aligned with the anatomical axis. Pins can be placed in the IM hole locator to assist with additional stability. The drill bush may also be lightly impacted onto the distal femur for additional stability.
  • Manufacturer
    DePuy Orthopaedics, Inc.
  • 1 Event
    • Recall of Device Recall HP LCS IM Hole Locator instrument
Device Recall SpineFrontier PedFuse Pedicle Screw System
  • Model / Serial
    Lot/Serial Numbers: 06440-0000, 06441-0000, AG24
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including TX, OH, VA, and Washington, DC.
  • Product Description
    lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164
  • Manufacturer
    SpineFrontier, Inc.
  • 1 Event
    • Recall of Device Recall SpineFrontier PedFuse Pedicle Screw System
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Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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