Implants & Prosthetics

Enovis EMPOWR 3D Knee Tibial Inserts Recalled for Incorrect Labeling

• Sold in 13 states
• Sold at Hospitals, Surgical Centers +1 more

Alphatec Spine, Inc.: IdentiTi ALIF Graft Bolts Recalled for Breakage Risk During Surgery

• Sold in 32 states
• Sold at Hospitals, Surgical Centers +1 more
• Reports of intraoperative graft bolt implantation breakages.

ProPort Plastic Implantable Ports Recalled for Reservoir Separation Risk

• Distributed nationwide
• Sold at hospital suppliers, medical distributors
• 30,146 units affected

Hologic, Inc: BioZorb 3D Bioabsorbable Markers Recalled for Adverse Events and Complications

• Distributed nationwide
• Sold at Hospitals, Surgical Centers +1 more
• Complaints describe complications including pain, infection, rash, device migration, erosion, seroma, and the need for medical removal.

ELEOS Limb Salvage Systems Recalled for Potential Sterile Seal Breach

• Sold in 18 states
• Sold at Onkos Surgical direct distribution
• Potential microbial contamination due to seal breach contamination

Abbott Medical: Abbott Infinity Pulse Generators Recalled for Premature Battery Depletion

• Sold in 36 states
• Sold at Hospitals, Surgical Centers +1 more
• 33,788 units affected

LivaNova SenTiva and SenTiva Duo VNS Generators Recalled for Stimulation Failure

• Sold in 39 states
• Sold at Authorized medical distributors, Hospitals +1 more
• 81,654 units affected

Biomet, Inc.: Vanguard Knee System AS Tibial Bearing Recalled for Manufacturing Damage

• Sold in Indiana
• Sold at Hospitals, Medical facilities +1 more

SIN Epikut S Plus CM Dental Implants Recalled for Incorrect Diameter Labeling

• Sold in 10 states
• Sold at Dental distributors, Medical supply channels

LINK SymphoKnee Augments Recalled for Missing Screw Threads

• Sold in 17 states
• Sold at Authorized Medical Device Distributors, Surgical Centers +1 more

Ossur H / F: RHEO KNEE and RHEO KNEE XC Recalled for Firmware Issues and Fall Risk

• Sold in 39 states
• Sold at Authorized prosthetic clinics, Specialty healthcare providers

Evolution MP Knee Implants Recalled for Incorrect Packaging and Labeling

• Distributed nationwide
• Sold at hospitals, surgical centers +1 more

Orthofix Fitbone Trochanteric Nails Recalled for Potential Bending

• Distributed nationwide
• Sold at Authorized medical distributors

Stryker CinchLock Flex Knotless Anchors Recalled for Pullwire Breakage Risk

• Distributed nationwide
• Sold at Hospitals, Surgical Centers +1 more
• Increase in complaints regarding pullwire breakage; specific injury counts not provided.

Waldemar Link GmbH & Co. KG (Mfg Site): Lubinus Hip Prosthesis Stems Recalled Due to Misleading Labeling

• Sold in 20 states
• Sold at Authorized medical distributors, Surgical centers +1 more

Canturio Smart Extension CSE Implant Recalled for Labeling Error

• Sold in Indiana
• Sold at hospitals, surgical centers +1 more

Altivate Reverse Torx Peripheral Screws Recalled for Incorrect Size Labeling

• Sold in 18 states
• Sold at RFK Medical Inc., Evolution Medical +12 more

Howmedica Osteonics Corp.: Trident II Acetabular Hip Shells Recalled for Excessive Deburring

• Distributed nationwide
• Sold at Hospitals, Surgical Centers +1 more

Encore Medical, LP: RSP Glenoid Baseplate Recalled for Surgical Tool Engagement Defect

• Sold in 18 states
• Sold at DJO Surgical, authorized medical distributors

Howmedica Osteonics Corp.: Custom Made GMRS Extension Piece Recalled for Design Mismatch

Staar Surgical Company: EVO Visian Implantable Lenses Recalled for Not Meeting Specifications

• Sold in 38 states
• Sold at Authorized ophthalmology clinics, specialty eye surgery centers

Affixus Antegrade Femoral Nails Recalled for Potential Fracture Risk

• Sold in 14 states
• Sold at Authorized medical device distributors, Hospitals +1 more

EMPOWR 3D Knee Tibial Inserts Recalled for Packaging Discrepancy

• Sold in 18 states
• Sold at Hospitals, Surgical Centers

Fixone, Genesis, and AlternatiV+ Surgical Anchors Recalled for Device Failure

• Sold in California, Puerto Rico
• Sold at Hospitals, Surgical centers +1 more