Category

Medical Implants Recalls

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

1,784 recalls
High RiskFDA
Nobel Biocare Usa Llc
Abutment Retrieval Instrument Zirconia CC RP/WP, Article No. 37882 and Abutment Retrieval Kit, Article No. 37508 (Article No. 37882 was a...
Medical Implants·149 affected·Jun 22, 2015
High RiskFDA
Allergan Inc
Natrelle 133 Series Tissue Expanders Product Usage: Natrelle 133 Series Tissue Expander is intended for temporary subcutaneous implan...
Medical Implants·167 affected·Jun 18, 2015
High RiskFDA
Allergan Inc
Natrelle CUI Series Tissue Expanders. Product Usage: Natrelle CUI Series Tissue Expander has been designed for temporary implantation...
Medical Implants·23 affected·Jun 18, 2015
High RiskFDA
B. Braun Interventional Systems
Celsite Implantable Access Port System, model ST301. The Celsite Implantable Access Port Systems (Celsite port systems) are implantable ...
Medical Implants·11 affected·Jun 16, 2015
High RiskFDA
Cryolife, Inc.
On-X Prosthetic Heart Valve Product Usage: Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic...
Medical Implants·52 affected·Jun 12, 2015
High RiskFDA
Allergan Inc
Natrelle Re-sterilizable Breast Implant Sizer, Size: 410 cc, Style No. MSZFX410. The product is packaged in a thermoformed tray (doubl...
Medical Implants·9 affected·Jun 8, 2015
High RiskFDA
Cochlear Americas Inc.
Cochlear Nucleus Sterile Silicone Template Product Usage: The Cochlear Nucleus Sterile Silicone Template is used in the sterile fiel...
Medical Implants·26 affected·Jun 5, 2015
High RiskFDA
Smith & Nephew, Inc.
Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING FEMORAL HEAD, STERILE R, Rx only, REF Numbers: 74121138 (38 MM), 74123140 (40 MM), 7412114...
Medical Implants·5,987 affected·Jun 3, 2015
High RiskFDA
Synthes, Inc.
Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended...
Medical Implants·132,564 affected·May 28, 2015
High RiskFDA
Bausch & Lomb Surgical, Inc.
Bausch & Lomb SoFlex SE Foldable intraocular Lens Product Usage: The SofPort/SoFlex IOLs are intended for primary implantation in the...
Medical Implants·72,773 affected·May 26, 2015
High RiskFDA
Rti Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Bullet-Tip PEEK VBR/IBF System, 32mm(l) 13mm(H) Implant 32-13-32 UDI (01)008464680341 08(17)191218(10)200827; T-Plus PEEK VBR/IBF System,...
Medical Implants·18 affected·May 21, 2015
High RiskFDA
Smith & Nephew, Inc.
R3(TM) 28 MM I.D., 60 MM O.D. CONSTRAINED LINER, REF 71339160, QTY: (1), STERILE EO, Product Usage: The R3 Constrained liner Acetabu...
Medical Implants·40 affected·May 6, 2015
High RiskFDA
Smith & Nephew, Inc.
R3(TM) 22 MM I.D., 58 MM O.D. CONSTRAINED LINER, REF 71339158, QTY: (1), STERILE EO. Product Usage: The R3 Constrained liner Acetabul...
Medical Implants·12 affected·May 6, 2015
High RiskFDA
Smith & Nephew, Inc.
R3(TM) 22 MM I.D., 56 MM O.D. CONSTRAINED LINER, REF 71339156, QTY: (1), STERILE EO. Product Usage: The R3 Constrained liner Acetabul...
Medical Implants·0 affected·May 6, 2015
RecallFDA
Biomet, Inc.
MCK Maximum Congruent Knee System, BIOMET FINNED PRI STEM 40MM; 80 x 10MM; 80 x 12.5 MM; 80 x 15 MM Knee joint replacement prostheses ...
Medical Implants·1,315 affected·Apr 16, 2015
CriticalFDA
Laax, Inc.
TIGERPAW System II, Part number C-TP-1509 (9 connector) The TigerPaw System II is an implantable occlusion Fastener to be placed on ...
Medical Implants·4,154 affected·Mar 25, 2015
CriticalFDA
Laax, Inc.
TIGERPAW System II, Part number C-TP-1507 (7 connector) The TigerPaw System II is an implantable occlusion Fastener to be placed on ...
Medical Implants·4,154 affected·Mar 25, 2015
High RiskFDA
Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic Dual Chamber Temporary External Pacemaker, Model 5392. Product Usage: The temporary pacemaker is used with a cardiac paci...
Medical Implants·6,040 affected·Mar 17, 2015
High RiskFDA
Bard Access Systems
PowerLoc MAX Safety Winged Infusion Set, Product Code 0132215 The PowerLoc MAX Safety Winged Infusion Set is intended for use in the a...
Medical Implants·700 affected·Mar 13, 2015
High RiskFDA
Nobel Biocare Usa Llc
NOBELREPLACE Tapered Groovy RP 4.3x10mm, Article No. 32216. Nobel Biocare's Dental Implants are root-form endosseous implants intended t...
Medical Implants·74 affected·Mar 9, 2015
High RiskFDA
Nobel Biocare Usa Llc
Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105. Nobel Biocare's Dental Implants are root-form endosseous implants intended ...
Medical Implants·23 affected·Mar 9, 2015
High RiskFDA
Nobel Biocare Usa Llc
NOBELREPLACE Tapered Groovy 6.0 6x8mm, Article No. 32223. Nobel Biocare's Dental Implants are root-form endosseous implants intended to ...
Medical Implants·7 affected·Mar 9, 2015
High RiskFDA
Nobel Biocare Usa Llc
Replace Select Tapered TiU NP 3.5x13mm, Article No. 29402. Nobel Biocare's Dental Implants are root-form endosseous implants intended to...
Medical Implants·17 affected·Mar 9, 2015
High RiskFDA
In2bones, Sas
DUAFIT(R) PIP 0o CA SIZE 3, REF A60 SP003, STERILE R, Rx only. Interphalangeal implant.
Medical Implants·15 affected·Mar 9, 2015
High RiskFDA
Codman & Shurtleff, Inc.
CODMAN 3000 Series Refill Set- Huber needles. Used in combination with the CODMAN 3000 Series Constant Flow Implantable Pump CATALOG NO...
Medical Implants·5,463 affected·Mar 5, 2015
CriticalFDA
Cardiovascular Systems, Inc.
Diamondback 360 Coronary Orbital Atherectomy System, Model Number: DBEC-125. The system is indicated to facilitate stent delivery in p...
Medical Implants·30 affected·Mar 4, 2015
High RiskFDA
Depuy Orthopaedics, Inc.
LCS COMPLETE RPS inserts, various sizes. Knee prosthesis component for orthopedic surgery.
Medical Implants·28,732 affected·Mar 4, 2015
High RiskFDA
Depuy Orthopaedics, Inc.
LCS COMPLETE RPS Femoral Implants, various sizes and orientation. Knee prosthesis component for orthopedic surgery.
Medical Implants·19,059 affected·Mar 4, 2015
High RiskFDA
Ossur H / F
The Rheo Knee bionic prosthetic is to be used exclusively for fittings of lower extremity amputations. RHEO KNEE uses Artificial Intelli...
Medical Implants·4,715 affected·Feb 26, 2015
High RiskFDA
Pega Medical Inc.
GAP Nail 4.8mm (diameter size) of the GAP ENDO-EXO MEDULLARY SYSTEM. Catalog number GAP-N48-16; GAP-N48-18; GAP-N48-26; GAP-N48-28. P...
Medical Implants·7 affected·Feb 20, 2015
High RiskFDA
Exactech, Inc.
Equinoxe 44mm Short Humeral Head Catalog Number 310-01-44. Orthopedic shoulder implant component.
Medical Implants·112 affected·Feb 13, 2015
High RiskFDA
Aaren Scientific, Incorporated
Intraocular Lens (IOL), Part No. EC-3 PAL, Diopter: 17.5, 18.0, 18.5, 19.0, 19.5, 21.5, 23.5, 9.0, 22.5, 23.0, 21.0, 24.0. The device...
Medical Implants·28 affected·Feb 13, 2015
High RiskFDA
Exp Pharmaceutical Services Corp
Medical Device Exchange ETS FLEX 45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, 45MM STAPLE; Pouch, Tyvek/Mylar, Sterile, Single Use Only; ...
Medical Implants·3 affected·Feb 11, 2015
High RiskFDA
Exp Pharmaceutical Services Corp
Medical Device Exchange SECURESTRAP 5mm Absorbable Strap Fixation Device; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog nu...
Medical Implants·2 affected·Feb 11, 2015
High RiskFDA
Depuy Orthopaedics, Inc.
SMARTSET GHV Gentamicin Bone Cement. A self-curing, radiopaque, polymethyl methacrylate based cement containing antibiotic. It is used f...
Medical Implants·1,267 affected·Feb 11, 2015
High RiskFDA
Exp Pharmaceutical Services Corp
Medical Device Exchange 10x40 Airway Stent System; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 90129-209; EXP (r...
Medical Implants·1 affected·Feb 11, 2015
High RiskFDA
Exp Pharmaceutical Services Corp
Medical Device Exchange -SYSTEM, TACKER SKIN 5MM; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 6206; EXP (repacka...
Medical Implants·3 affected·Feb 11, 2015
High RiskFDA
Philips Medical Systems, Inc.
Philips Healthcare INTEGRIS vascular System Model : 722122 Product Usage: The Allura Xper series is intended for use in cardiovasc...
Medical Implants·3 affected·Feb 3, 2015
High RiskFDA
Philips Medical Systems, Inc.
Philips Healthcare Xper vascular systems R7.6 Model : 722134 Product Usage: The Allura Xper series is intended for use in cardiovas...
Medical Implants·22 affected·Feb 3, 2015
High RiskFDA
Philips Medical Systems, Inc.
Philips Healthcare INTEGRIS H5000F/Allura 9F Model : 722017 Product Usage: The Allura Xper series is intended for use in cardiovas...
Medical Implants·1 affected·Feb 3, 2015
High RiskFDA
Philips Medical Systems, Inc.
Philips Healthcare Allura Xper Series: Allura Xper FD10 Allura Xper FD10/10 Allura Xper FD20 Allura Xper FD21 Allura Xper FD22 Allu...
Medical Implants·9 affected·Feb 3, 2015
High RiskFDA
Philips Medical Systems, Inc.
Philips Healthcare INTEGRIS cardio system Model : 722121 Product Usage: The Allura Xper series is intended for use in cardiovascul...
Medical Implants·8 affected·Feb 3, 2015
High RiskFDA
Synthes, Inc.
Synthes Inserter for Titanium Elastic Nails; The Inserter for Titanium Elastic Nails (TEN) is intended for fixation of diaphyseal fractur...
Medical Implants·1,550 affected·Feb 3, 2015
High RiskFDA
Microport Orthopedics Inc.
EVOLUTION MP TIBIAL BASE, REF ETPKN8SR, SIZE 8 RIGHT, TYPE PRIMARY, FIT CEMENTED, STYLE KEELED, STERILE R, Rx ONLY, MicroPort Orthopedics...
Medical Implants·17 affected·Feb 2, 2015
High RiskFDA
Southern Implants, Inc
MAX-TL 9.0 x 7.0 mm Implant, Catalog No. 15711K; Z-MAX Implant 9.0 x 7 mm Length, Catalog No. Z-MAX9-7. Dental implant. Product Usa...
Medical Implants·130 affected·Jan 23, 2015
High RiskFDA
Zimmer Dental Inc
GemLock Long Hex Driver, Catalog RHL2.5; Also distributed within the Tapered SwissPlus & SwissPlus Implant Systems Kits, Surgical, Comple...
Medical Implants·627 affected·Jan 22, 2015
High RiskFDA
Biomet, Inc.
Mallory Head 4 Finned Acetabular Shell 50 mm, PN 13-104150, hip prosthesis component (Ringloc)
Medical Implants·17 affected·Jan 9, 2015
High RiskFDA
Biomet, Inc.
Ringloc+ Acetabular Shell Finned 52 mm, PN 16-104152, hip prosthesis component.
Medical Implants·17 affected·Jan 9, 2015