Category

Medical Implants Recalls

1,784 medical implants recalls on record from CPSC, FDA, and USDA.

1,784 recalls
CriticalFDA
Medtronic Neuromodulation
Medtronic SynchroMed II Implantable Drug Infusion System. This system includes: Model 8870 Software Application Card, Model 8840 N'Visi...
Medical Implants·22,298 affected·Oct 3, 2016
High RiskFDA
Sorin Group Usa, Inc.
The ORCHESTRA PLUS Programmer A portable device, equipped with a microprocessor used to program and interrogate Sorin implantable pac...
Medical Implants·586 affected·Sep 29, 2016
High RiskFDA
Zimmer Biomet, Inc.
Zimmer¿ Gender Solutions" Patellofemoral Joint Prosthesis Milling Handpiece
Medical Implants·703 affected·Sep 28, 2016
High RiskFDA
Sequent Medical Inc
VIA 27 Microcatheter, Part No. FG27-154-01, Model No. VIA-27-154-01 The VIA 27 is intended for the introduction of non-liquid interve...
Medical Implants·618 affected·Sep 23, 2016
High RiskFDA
Encore Medical, Lp
Empowr PS Knee System Box Cut Guide The EMPOWER PS Box Cut Guide is used to make the housing resection for the post of the posterior sta...
Medical Implants·162 affected·Sep 19, 2016
High RiskFDA
Tornier, Inc
Aequalis Fx2 implant parts and instrument trays. Insert component : Part Numbers DWK204B-DWK206B, DWK224B-DWK226B, DWK230B-DWK23B, DW...
Medical Implants·30 affected·Sep 19, 2016
High RiskFDA
Keystone Dental Inc
Keystone Dental PrimaConnex¿ Straight Implant TC, RD Internal Connection 4.0 x 11.5mm. Product code:15613K Implants are intended for us...
Medical Implants·55 affected·Sep 15, 2016
High RiskFDA
Biomet 3i, Llc
BIOMET 3i LOW PROFILE 17¿ ABUTMENT 4.1MM(D) X 4MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component dir...
Medical Implants·216 affected·Sep 14, 2016
High RiskFDA
Biomet 3i, Llc
BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured prosthetic compone...
Medical Implants·191 affected·Sep 14, 2016
High RiskFDA
Biomet 3i, Llc
BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic compo...
Medical Implants·735 affected·Sep 14, 2016
High RiskFDA
Biomet 3i, Llc
BIOMET 3i LOW PROFILE ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directl...
Medical Implants·50 affected·Sep 14, 2016
High RiskFDA
Biomet 3i, Llc
BIOMET 3i LOW PROFILE ABUTMENT 4.1MM(D) X 1MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directl...
Medical Implants·160 affected·Sep 14, 2016
High RiskFDA
Biomet 3i, Llc
BIOMET 3i LOW PROFILE ABUTMENT TITANIUM RETAINING SCREW An endosseous dental implant abutment is a premanufactured prosthetic component ...
Medical Implants·1,633 affected·Sep 14, 2016
High RiskFDA
Biomet 3i, Llc
BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic...
Medical Implants·525 affected·Sep 14, 2016
High RiskFDA
Biomet 3i, Llc
BIOMET 3i CERTAIN LOW PROFILE ABUTMENT 4.1MM(D) X 1MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component...
Medical Implants·123 affected·Sep 14, 2016
High RiskFDA
Biomet 3i, Llc
BIOMET 3i LOW PROFILE 30¿ ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component di...
Medical Implants·175 affected·Sep 14, 2016
High RiskFDA
Biomet 3i, Llc
BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic...
Medical Implants·101 affected·Sep 14, 2016
High RiskFDA
Biomet 3i, Llc
BIOMET 3i LOW PROFILE 17¿ ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component dir...
Medical Implants·246 affected·Sep 14, 2016
High RiskFDA
Biomet 3i, Llc
BIOMET 3i LOW PROFILE ABUTMENT (NON-HEXED) PICK-UP IMPRESSION COPING An endosseous dental implant abutment is a premanufactured prosth...
Medical Implants·458 affected·Sep 14, 2016
High RiskFDA
Biomet 3i, Llc
BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured prosthetic...
Medical Implants·46 affected·Sep 14, 2016
High RiskFDA
Biomet 3i, Llc
BIOMET 3i CERTAIN LOW PROFILE ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component...
Medical Implants·108 affected·Sep 14, 2016
High RiskFDA
Biomet 3i, Llc
BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 1MM(H) An endosseous dental implant abutment is a premanufactured prosthetic compone...
Medical Implants·204 affected·Sep 14, 2016
High RiskFDA
Biomet 3i, Llc
BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic compone...
Medical Implants·137 affected·Sep 14, 2016
High RiskFDA
Biomet 3i, Llc
BIOMET 3i CERTAIN LOW PROFILE 30¿ ABUTMENT 3.4MM(D) X 5MM(H) An endosseous dental implant abutment is a premanufactured prosthetic compo...
Medical Implants·27 affected·Sep 14, 2016
High RiskFDA
Biomet 3i, Llc
BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 4MM(H) An endosseous dental implant abutment is a premanufactured prosthetic...
Medical Implants·108 affected·Sep 14, 2016
High RiskFDA
Biomet 3i, Llc
BIOMET 3i LOW PROFILE ABUTMENT NON-HEXED PREFORMANCE TEMPORARY CYLINDER An endosseous dental implant abutment is a premanufactured pro...
Medical Implants·270 affected·Sep 14, 2016
High RiskFDA
Biomet 3i, Llc
BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 3.4MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic compo...
Medical Implants·127 affected·Sep 14, 2016
High RiskFDA
Biomet 3i, Llc
BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 4MM(H) An endosseous dental implant abutment is a premanufactured prosthetic compone...
Medical Implants·124 affected·Sep 14, 2016
High RiskFDA
Biomet 3i, Llc
BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 3.4MM(D) X 4MM(H) An endosseous dental implant abutment is a premanufactured prosthetic compo...
Medical Implants·53 affected·Sep 14, 2016
High RiskFDA
Osteogenics Biomedical, Inc.
Cytoplast Titanium-Reinforced Posterior Singles Membrane A temporarily implantable material (non-resorbable) for use as a space-makin...
Medical Implants·32 affected·Sep 7, 2016
High RiskFDA
Abbott Medical Optics Inc. (amo)
TECNIS OptiBlue 1-Piece Intraocular Lens (IOL), Model No. ZCB00V The product is indicated for implantation for the visual correction of ...
Medical Implants·131 affected·Aug 26, 2016
High RiskFDA
Abbott Medical Optics Inc. (amo)
TECNIS 1-Piece IOL with the TECNIS iTec Preloaded Delivery System, Model No. PCB00 The product is indicated for implantation for the vis...
Medical Implants·217 affected·Aug 26, 2016
High RiskFDA
Abbott Medical Optics Inc. (amo)
TECNIS Symfony Extended Range of Vision IOL, Model No. ZXR00 The product is indicated primary implantation for the visual correction of ...
Medical Implants·10 affected·Aug 26, 2016
High RiskFDA
Abbott Medical Optics Inc. (amo)
SENSAR Foldable IOL with OptiEdge Design, Model No. AR40e The product is indicated for implantation for the visual correction of aphakia...
Medical Implants·84 affected·Aug 26, 2016
High RiskFDA
Abbott Medical Optics Inc. (amo)
SENSAR 1-Piece IOL, Model No. AAB00 The product is indicated for implantation for the visual correction of aphakia in adult patients in ...
Medical Implants·1 affected·Aug 26, 2016
High RiskFDA
Abbott Medical Optics Inc. (amo)
TECNIS Multifocal Foldable Acrylic Intraocular Lens, Model No. ZMA00 The product is indicated for primary implantation for the visual co...
Medical Implants·41 affected·Aug 26, 2016
High RiskFDA
Zimmer Biomet, Inc.
Coonrad/ Morrey Elbow Pin/ Bushing Replacement size Kit Extra Small. This product is sold sterile. The parts are placed into an inner cav...
Medical Implants·25 affected·Aug 16, 2016
High RiskFDA
Novarad Corporation
NovaPACS versions 8.4.7, 8.5.3, and 8.5.6. Distributed by Novarad Corporation. Picture archiving and communication system (PACS) Produc...
Medical Implants·90 affected·Aug 12, 2016
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure
Medtronic, Viva Quadripolar Implantable Cardioverter Defibrillators: Product Model VIVAXTCRT-D DTBA1D1, DTBA1D4 VI...
Medical Implants·78 affected·Aug 12, 2016
High RiskFDA
Zimmer Biomet, Inc.
Vanguard Distal Femoral Augment 75 X 5 RL/LM Product Usage:  Painful and disabled knee joint resulting from osteoarthritis, rheumato...
Medical Implants·5 affected·Aug 9, 2016
High RiskFDA
Mentor Texas, Lp.
CPX4 Breast Tissue Expander 650 cc : Product Usage: Tissue expanders can be used for breast reconstruction after mastectomy, correctio...
Medical Implants·30 affected·Aug 9, 2016
High RiskFDA
Mentor Texas, Lp.
MENTOR 2" Tall Height TE With Sutures 450cc PN: 354-9313 The MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue Expanders are used fo...
Medical Implants·70 affected·Aug 9, 2016
High RiskFDA
Zimmer Biomet, Inc.
Phoenix Recon Targeting Arm Guide, Surgical, Instrument for the sleeve and Orthopedic Manual Surgical Instruments for the Arm Product...
Medical Implants·31 affected·Aug 9, 2016
High RiskFDA
Mentor Texas, Lp.
MENTOR 2" Tall Height TE With Sutures 350cc PN: 354-9312 The MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue Expanders are used fo...
Medical Implants·65 affected·Aug 9, 2016
High RiskFDA
Mentor Texas, Lp.
Artoura Breast Tissue Expander 700 cc Product Usage: Tissue expanders can be used for breast reconstruction after mastectomy, correct...
Medical Implants·48 affected·Aug 9, 2016
High RiskFDA
Biomet 3i, Llc
3I OSSEOTITE CERTAIN DENTAL IMPLANTS, 4x11.5 mm, Sterile, Rx only.
Medical Implants·92 affected·Aug 8, 2016
High RiskFDA
Zimmer Biomet, Inc.
Vanguard 360 Revision Knee System Knee prostheses
Medical Implants·454 affected·Aug 8, 2016
High RiskFDA
Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics Patella Assembly Instrument, REF 3182-1000, Non-Sterile, NDC (01) 07613327215854 (10) The Scorpio Patella Assembl...
Medical Implants·2,039 affected·Aug 1, 2016