Implants & Prosthetics

Klassic BiPolar Head Recalled for Potential Sterility Risk

• Sold in 5 states
• Sold at Authorized medical device distributors, Surgical centers +1 more

Medtronic, Inc.: There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.

Preat Corp: Titanium Dental Abutments Recalled Due to Manufacturing Defect

• Sold in Arizona, Ohio, Pennsylvania
• Sold at Dental laboratories, Healthcare providers

Stryker T2 Greater Trochanter Nails Recalled for Mislabeled Left/Right Implants

• Sold in California, Missouri
• Sold at Hospitals, Medical distributors

IMPULSE DYNAMICS (USA) INC: OPTIMIZER Implantable Pulse Generators Recalled for Charging Error Risk

• Distributed nationwide
• Sold at authorized medical distributors, hospitals +1 more

JuggerKnot Mini Soft Anchors Recalled for Incorrect Size Labeling

• Distributed nationwide
• Sold at Surgical supply distributors, Direct medical sales

Wishbone Medical, Inc.: WishFIX Growth Control Plating System Recalled for Incorrect Implant Material

• Sold in Florida, New Jersey, Connecticut
• Sold at Direct distribution

Smith & Nephew, Inc.: JOURNEY II Knee Prosthesis Inserts Recalled Due to Mislabeling Error

• Distributed nationwide
• Sold at Hospitals, Surgical Centers

Zimmer, Inc.: M/L Taper Hip Prosthesis Recalled for Size Labeling Errors

• Sold in 8 states
• Sold at Hospitals, Surgical Centers

Link Prosthesis and Trial Heads Recalled for Labeling and Color Errors

• Sold in 7 states
• Sold at Medical device distributors, Surgical centers +1 more

Zimmer Comprehensive Shoulder Stems Recalled for Connection Issues

• Distributed nationwide
• Sold at Hospitals, Medical distributors +1 more
• Excess material remaining within the taper contamination

XTANT Irix-A Lumbar Fusion System Recalled for Incorrect Expiration Dates

• Sold in 7 states
• Sold at Hospitals, Surgical Centers

Abbott Medical: Liberta RC Deep Brain Stimulators Recalled for Unexpected Power Shut-Off

• Sold in 32 states
• Sold at Authorized Medical Distributors, Hospitals

EMPOWR Acetabular System and Knee Inserts Recalled for Packaging Errors

• Sold in 14 states
• Sold at Hospitals, Surgical Centers +1 more

Conformis Acetabular Hip System Liners Recalled for Incorrect Labeling

• Sold in 4 states
• Sold at Hospitals, Surgical centers

Artegraft Collagen Vascular Grafts Recalled for Unapproved Material Sourcing

• Sold in 17 states
• Sold at Authorized Medical Distributors, Direct Hospital Sales

Howmedica Osteonics Corp.: Triathlon Universal TS Baseplate Recalled for Surgical Locking Tab Defect

• Sold in 7 states
• Sold at Stryker Branch/Agency, Medical Facilities

Waldemar Link GmbH & Co. KG (Mfg Site): MobileLink Acetabular Cup System Recalled for Incorrect Offset Labeling

• Sold in Alabama, New Jersey, Nevada
• Sold at specialty medical distributors

Boston Scientific Reliance Defibrillation Leads Recalled for Coil Calcification

• Distributed nationwide
• Sold at Hospitals, Surgical Centers +1 more
• Most serious harm is death or need for cardiac resuscitation.

TMJ Bilateral Implants Recalled for Incorrect Screw Hole Position

• Sold in 15 states
• Sold at Hospitals and specialized surgical centers

Nalu Medical, Inc.: Neurostimulation Kits Recalled Due to Potential Implant Failure

• Sold in 8 states
• Sold at Nalu Medical, Inc. authorized distributors, Medical facilities

VOLT Wrist Treatment System Plates Recalled for Incorrect Thread Orientation

• Sold in Pennsylvania
• Sold at Medical device distributors, Hospitals +1 more

Artivion, Inc: CryoValve and CryoPatch Heart Grafts Recalled for Invalid Test Results

• Sold in 4 states
• Sold at Hospitals, Surgical Centers

Cartiva Synthetic Cartilage Implants Recalled Due to Higher Failure Rates

• Sold in 35 states
• Sold at Hospitals, Surgical Centers +1 more
• Higher-than-expected rates of implant subsidence, displacement, nerve damage, and fragmentation requiring removal or revision.