Go Backs

Implants & Prosthetics

AllImplants & Prosthetics(225)Monitoring Devices(270)Diagnostic Equipment(818)Home Healthcare(231)Contact Lenses & Vision(17)Surgical Equipment(890)

225 recalls

per page
Zimmer
Medium RiskFDA Device

Zimmer NexGen LPS Flex Knee Prosthesis Recalled for Labeling Discrepancy

  • Sold in 10 states
  • Sold at Hospitals, Surgical Centers +1 more
Recalled
Added
Abbott Medical
High RiskFDA Device

Aveir Leadless Pacemakers Recalled for Premature Battery Failure

  • Sold in Florida, South Carolina, West Virginia
  • Sold at Hospitals, medical facilities +1 more
Recalled
Added
Artivion
High RiskFDA Device

Artivion, Inc: CryoValve SG Pulmonary Heart Valve Recalled for Staphylococcus aureus

  • Sold in Ohio
  • Sold at specialty medical facilities
  • Staphylococcus aureus contamination
Recalled
Added
Centinel Spine
Medium RiskFDA Device

Prodisc C SK Cervical Discs Recalled for Mislabeled Size

  • Sold in 8 states
  • Sold at Direct distribution to hospitals/clinics
Recalled
Added
W L Gore & Associates
Medium RiskFDA Device

GORE ACUSEAL Vascular Grafts Recalled for Risk of Layer Separation

  • Sold in 51 states
  • Sold at Hospitals, Surgical Centers +1 more
  • Reports of delamination resulting in reduced access flow, cannulation difficulties, and bleeding/bruising.
Recalled
Added
Onkos Surgical
Medium RiskFDA Device

Onkos Surgical ELEOS Collar Stems Recalled for Packaging Mislabeling

  • Sold in California, Kentucky, Wisconsin
  • Sold at Hospital providers, Surgical centers
Recalled
Added
Inspire Medical Systems
Critical RiskFDA Device

Inspire Medical Systems Inc.: Inspire Model 3028 Pulse Generator Recalled for Electrical Malfunction Risk

  • Distributed nationwide
  • Sold at Hospitals, Surgical Centers +1 more
  • Malfunction requiring revision surgery reported.
Recalled
Added
Onkos Surgical
Medium RiskFDA Device

ELEOS Midsections Recalled for Surgical Assembly Challenges

  • Sold in 7 states
  • Sold at Authorized Medical Distributors
Recalled
Added
DePuy Orthopaedics
Medium RiskFDA Device

DePuy Orthopaedics, Inc.: ATTUNE AFFIXIUM Cementless Fixed Bearing Knee Recalled for Incorrect Labeling

  • Sold in 4 states
  • Sold at Authorized orthopedic distributors, Surgical centers +1 more
Recalled
Added
LivaNova USA
Medium RiskFDA Device

LivaNova USA, Inc.: SenTiva and SenTiva DUO VNS Therapy Generators Recalled for Therapy Failure

  • Sold in 39 states
  • Sold at Authorized Medical Distributors, Specialized Surgical Centers
Recalled
Added
BALT USA
Medium RiskFDA Device

BALT USA, LLC: Optima and Prestige Coil Systems Recalled for Delivery Pusher Corrosion

  • Sold in 28 states
  • Sold at Authorized medical distributors, Direct clinical sales
  • Solder flux residue contamination
Recalled
Added
Onkos Surgical
Medium RiskFDA Device

Onkos Surgical ELEOS Limb Salvage System Implants Recalled for Unknown Substance

  • Sold in 25 states
  • Sold at Hospitals, Surgical Centers +1 more
  • Unidentified substance contamination
Recalled
Added
Biomet
Medium RiskFDA Device

Biomet ZipTight AC Joint Implants Recalled for Missing Button Assembly

  • Distributed nationwide
  • Sold at Medical distributors, Hospitals +1 more
Recalled
Added
Medtronic
Medium RiskFDA Device

Medtronic Abre Venous Stents Recalled for Potential Migration Risk

  • Distributed nationwide
  • Sold at Hospitals, Medical specialty distributors
Recalled
Added
Medtronic Sofamor Danek USA
Medium RiskFDA Device

Medtronic Catalyft Expandable Interbody System Recalled for Collapse Risk

  • Distributed nationwide
  • Sold at Authorized Medtronic medical device distributors, Hospitals +1 more
  • Neurological injury, migration, and subsidence noted as potential outcomes; actual injury counts not specified in initial alert.
Recalled
Added
Limacorporate S.p.A
Medium RiskFDA Device

Limacorporate S.p.A: PRIMA TT Glenoid Baseplates Recalled Due to Potential Loosening

  • Sold in 6 states
  • Sold at Hospitals, Surgical Centers
Recalled
Added
Vascutek
Medium RiskFDA Device

Gelsoft Plus and Gelweave Vascular Grafts Recalled for Expiration Date Error

  • Sold in 51 states
  • Sold at Authorized Medical Device Distributors, Hospitals
  • 37,430 units affected
Recalled
Added
Preat
Medium RiskFDA Device

Preat Astra EV-Compatible Digital Analogs Recalled for Manufacturing Error

  • Sold in 10 states
  • Sold at Dental clinics, Healthcare providers
Recalled
Added
Medium RiskFDA Device

LinkSymphoKnee Tibial Components Recalled for Incorrect Security Screws

  • Sold in 4 states
  • Sold at Hospitals, Surgical Centers +1 more
Recalled
Added
Medium RiskFDA Device

Endo Model Knee Fusion Nail SK Recalled for Incorrect Locking Screw Assembly

  • Sold in Alabama, Georgia, Texas
  • Sold at Medical distributors, Surgical centers +1 more
Recalled
Added
High RiskFDA Device

Boston Scientific Neuromodulation Corporation: Deep Brain Stimulation Generators Recalled Due to Possible Device Resets

  • Sold in 47 states
  • Sold at Hospitals, Medical Centers +1 more
  • Device resets may lead to transient loss of stimulation and worsening symptoms, which may lead to patient requests for surgical intervention.
Recalled
Added
W L Gore & Associates
Medium RiskFDA Device

W L Gore & Associates, Inc.: Due to packaging defects, sterility assurance and heparin activity may be compromised.

  • 43,001 units affected
Recalled
Added
Zimmer
Medium RiskFDA Device

Zimmer, Inc.: CPT Hip Joint Prosthesis Recalled for Risk of Femoral Fracture

  • Distributed nationwide
  • Sold at Hospitals, Surgical Centers +1 more
Recalled
Added
Biomet
Medium RiskFDA Device

Biomet, Inc.: Biolox Ceramic Option Heads Recalled Due to Incorrect Packaging and Sizing

  • Sold in 9 states
  • Sold at Authorized Medical Distributors
  • One product complaint received; no specific injuries reported.
Recalled
Added