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U.S. Department of Health and Human Services

Medical Device Recalls

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Gentell Hydrogel Ag 4x8, model no. GEN-11820 - Product Usage: Under the care of a healthcare profess... 2 03/05/2020 Gentell, Inc
Truliant Splined Stem Extension, 18mm x 120mm - Product Usage: The devices are used in a cemented to... 2 02/26/2020 Exactech, Inc.
TLC-2000 Therapeutic Medical Laser System - Product Usage: Indicated for the temporary relief of kne... 3 02/13/2020 Theralase Inc.
Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indicated for stereotaxic sur... 2 02/11/2020 Blue Ortho
REF 800-05-035, ENZTEC FEMORAL IMPACTOR - DJO, (01) 09421028110624 (10) 999999, To be used only with... 2 01/24/2020 Enztec Limited
DeRoyal KNEE BRACE, WARRIOR RECOVERY: 1) REF KB9000-01 2) REF 11-450A-00 3) REF 1150UTPP 2 12/19/2019 DeRoyal Industries Inc
smith&nephew PROFIX Mallet, 750 GRAMS, REF 71512452 - Product Usage: The PROFIX Mallet is a reusable... 2 12/17/2019 Smith & Nephew, Inc.
iTotal CR Knee Replacement System Model Number: TCR-111-1111-010102 - Product Usage: The iTotal CR ... 2 12/12/2019 Conformis, Inc.
TLC-2000 Therapeutic Medical Laser System, Power Pack component TLC-2002 Used for the temporary rel... 3 12/05/2019 Theralase Inc.
TLC-2000 Therapeutic Medical Laser System, used for the temporary relief of knee pain. 3 12/05/2019 Theralase Inc.
BRASSELER KM166-310-35 Twist Drill Quick Connect Diameter 3.5 mm, Total Length 112mm, Effective Leng... 2 12/02/2019 Brasseler USA I Lp
Various Knee Systems, Item Nos. 32855411838 32855411840 32855411842 32855411843 32855420307 328... 2 11/07/2019 Zimmer Biomet, Inc.
Various Knee Systems for knee joint arthroplasty, knee prosthesis, Item Nos. 00522000100 0052200020... 2 11/07/2019 Zimmer Biomet, Inc.
TxRx 15Ch Knee Coil 3T QED part number:Q7000008 Siemens Model # 10185460 2 10/03/2019 Quality Electrodynamics LLC
TxRx 15CH Knee Coil 1.5T QED part number:Q7000016 Siemens Model # 10185453 2 10/03/2019 Quality Electrodynamics LLC
TxRx 15CH Knee Coil 3T QED part number: Q7000051 Siemens Model # 10606525 2 10/03/2019 Quality Electrodynamics LLC
TxRx Knee 15 Coil 1.5T QED part number: Q7000056 Siemens Model # 10606828 2 10/03/2019 Quality Electrodynamics LLC
TxRx Knee 15 Coil 1.5T QED part number: Q7000057 Siemens Model # 10606829 2 10/03/2019 Quality Electrodynamics LLC
TxRx 15CH Knee Coil 1.5T QED part number: Q7000050 Siemens Model # 10606524 2 10/03/2019 Quality Electrodynamics LLC
TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 LEFTTriathlon Femoral Distal Augments are used with T... 2 09/27/2019 Howmedica Osteonics Corp.
TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 RIGHT Catalog # 5541-A-202 - Product Usage: Triathlo... 2 09/27/2019 Howmedica Osteonics Corp.
TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 LEFT Catalog # 5541-A-201 - Product Usage: Triathlon... 2 09/27/2019 Howmedica Osteonics Corp.
TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 RIGHT Catalog # 5542-A-202 - Product Usage: Triathlo... 2 09/27/2019 Howmedica Osteonics Corp.
LEGION(TM) HEMI STEP TIBIAL WEDGE RK/HK, 5 MM, SIZE 3-4 LT.MDL/RT-LAT, REF 71423432 Product Usage... 2 09/12/2019 Smith & Nephew, Inc.
The LeMaitre Aortic Occlusion Catheter is a single lumen catheter with a latex balloon, it is offere... 2 09/03/2019 LeMaitre Vascular, Inc.
2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only) 2 06/16/2019 Mako Surgical Corporation
2.7 Degree Straight Sagittal Saw attachment (Mako Total Knee Application and Partial Knee Applicatio... 2 06/16/2019 Mako Surgical Corporation
Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-421930 Sy... 2 06/06/2019 Zimmer Biomet, Inc.
Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-421060 Pha... 2 06/06/2019 Zimmer Biomet, Inc.
Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-420324Phase... 2 06/06/2019 Zimmer Biomet, Inc.
Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-420322 Phas... 2 06/06/2019 Zimmer Biomet, Inc.
Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-420321 Phas... 2 06/06/2019 Zimmer Biomet, Inc.
Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-420323 Pha... 2 06/06/2019 Zimmer Biomet, Inc.
OMNIBotics iBlock Cutting Guide, 4146-1000 - Product Usage: The OMNIBotics iBlock Cutting Guide is a... 2 06/04/2019 OMNIlife science Inc.
Zimmer Biomet Alvarado Knee Holder Base Plate Assembly and Foot Piece, & Alvarado II Base Plate and ... 2 05/28/2019 Zimmer Surgical Inc
Integra Flowable Wound Matrix Catalog No: FWD301 Product Usage: Integra Flowable Wound Matrix i... 2 05/15/2019 Integra Limited
EZ Derm Porcine Xenograft, labeled as the following: a. EZ Derm 3x4 (8x10 cm) Non-Perforated, P... 2 04/30/2019 Molnlycke Health Care, Inc
Performance Series Sagittal Blade, Catalog Number 6125-127-100 Product Usage: The Stryker Heavy ... 2 04/24/2019 Stryker Instruments Div. of Stryker Corporation
Truliant Tibial Fit Tray Cemented SZ 3F / 3T, Catalog Number 02-022-45-3030 Product Usage: Knee ... 2 04/23/2019 Exactech, Inc.
iTotal CR Total Knee Replacement System, TCR-121-1111 (Catalog No.) / TCR-121-1111-010102 (Model No.... 2 04/08/2019 Conformis, Inc.
iTotal Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-111-1111 - 020102 2 03/30/2019 Conformis, Inc.
Gentrix Surgical Matrix Thick, 30 x 40cm, Catalog Number PSMT3040, Lot 013948 - Product Usage: Gentr... 2 03/21/2019 ACell, Inc
Gentrix Surgical Matrix Thick, 20 x 30cm, Catalog Number PSMT2030, Lot 013948 - Product Usage: Gentr... 2 03/21/2019 ACell, Inc
NexGenTrabecular Metal Tibial Half Block Augment, Left Lateral/Right Medial, Size 4 5MM Thickness W... 2 03/11/2019 Zimmer Trabecular Metal Technology, Inc.
NexGenTrabecular Metal Tibial Half Block Augment, Right Lateral/Left Medial, Size 4 5MM Thickness W... 2 03/11/2019 Zimmer Trabecular Metal Technology, Inc.
Instrument Tray, Basic T2 Femur Long Catalog #: 1806-9900 Product Usage: Knee Arthroplasty 2 03/06/2019 Stryker GmbH
Bag size #4 Custom Convenience Kits Usage: Surgical convenience kits labeled as the followin... 2 02/27/2019 American Contract Systems, Inc.
Vanguard Knee System Series-A Standard Patella sizes 34mm Item Number: 184766 2 02/23/2019 Zimmer Biomet, Inc.
Vanguard Knee System Series-A Standard Patella sizes 31mm Item Number: 184764 2 02/23/2019 Zimmer Biomet, Inc.
Genius Knee Cemented CR Femoral Component Product Usage: Knee replacement component 2 02/14/2019 Signature Orthopedics Pty Limited
Genius Knee Cemented Tibial Component Product Usage: Knee replacement component 2 02/14/2019 Signature Orthopedics Pty Limited
LINK STEM with Microporous Surface MP Reconstruction Prosthesis, CEMENTLESS (Size XS-0, D: 12mm, L: ... 2 01/14/2019 Waldemar Link GmbH & Co. KG (Mfg Site)
Presource Kit Total Joint Pack containing a double-wrapped basin component. Product Usage: This... 2 01/09/2019 Cardinal Health Inc.
NexGen® Complete Knee Solution Femoral Augment Block Distal only, 15mm, Size E with Screw Item Numb... 2 12/18/2018 Zimmer Biomet, Inc.
Vanguard Knee System -PS Open Box Femoral Right, 65 mm Item Number:183108 2 11/21/2018 Zimmer Biomet, Inc.
Vanguard Knee System -PS Open Box Femoral Left, 62.5 mm Item Number: 183126 2 11/21/2018 Zimmer Biomet, Inc.
Neodent® GM Mini Conical Abutment - Product Usage: Mini Conical Abutments are intermediary prostheti... 2 11/14/2018 Straumann Manufacturing, Inc.
Sterile Knee Instruments Disposable Fluted Headless Pins, DIA 3.2mm LNTH 89mm, REF 7650-2038A - Prod... 2 11/02/2018 Howmedica Osteonics Corp.
Femoral and Tibial Cutting Block Adapter Base. Brainlab knee, BrainLAB Image Guided Surgery System /... 2 10/11/2018 Brainlab AG
Conformis iTotal Cruciate Retaining (CR) Knee Replacement System Model: TCR-111-1111 2 10/02/2018 ConforMIS, Inc.
JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 74023113, 74023114, 7402311... 2 10/01/2018 Smith & Nephew, Inc.
JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 7402111... 2 10/01/2018 Smith & Nephew, Inc.
Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, ... 2 10/01/2018 Smith & Nephew, Inc.
Biomet Sports Medii cine Juggerknot Long Flex Drill Bit with Sleeve Nitinol intended to be used for ... 2 09/26/2018 Zimmer Biomet, Inc.
Vanguard 360 Revision Knee System 75x 5mm Universal Tibial Block Augment, Model Number 185224 I... 2 09/25/2018 Zimmer Biomet, Inc.
Vanguard 360 Revision Knee System 63x 10mm Universal Tibial Block Augment, Model Number 185221 ... 2 09/25/2018 Zimmer Biomet, Inc.
Optetrak Logic CC Stem Extension, 22mm x 160mm The OPTETRAK Logic CC Total Knee System is indicat... 2 09/20/2018 Exactech, Inc.
Makoplasty RIO Standard System; Ethernet to Fiber Optic Converter Catalog # 200933 Product Usage:... 2 09/15/2018 Mako Surgical Corporation
Foundation Modular Femoral Stem, Part Number, 220-10-110. Knee prosthesis component. The Founda... 2 08/31/2018 Encore Medical, Lp
P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830 2 08/29/2018 DePuy Orthopaedics, Inc.
Stryker Mako Vizadisc Knee Procedure Tracking Kit 2 08/24/2018 Mako Surgical Corporation
GENESIS II NON-POROUS CRUCIATE RETAINING FEMORAL COMPONENT, SIZE 6 RIGHT, REF 71420026 Knee prosthe... 2 08/22/2018 Smith & Nephew, Inc.
Persona Partial Knee System Spacer Block Alignment Tower, Item No. 42-5399-006-35 Product Usage: ... 2 08/18/2018 Zimmer Biomet, Inc.
Rio System Irrigation Clip - Catalog # 111690 Product Usage: The RESTORIS Partial Knee Applicati... 2 08/14/2018 Mako Surgical Corporation
Think Surgical Cutter, Flat, ®6.2mm x 144mm. For use only with the TCAT Computer-Assisted Tool. Pa... 2 08/06/2018 Think Surgical, Inc.
Apollo XT Suture Anchor, 5.5 x 15 Product Usage: Apollo XT Suture Anchors are intended for: Shou... 2 07/13/2018 Valeris Medical, LLC
Hyalomatrix, Product nos. 651105, 651103, 651104, and 651301 Product Usage: Hyalomatrix is a bi-... 2 07/11/2018 Anika Therapeutics, Inc.
Vanguard Complete Knee System; E1 Vanguard PS Tibial Bearing; Model Numbers EP-183664, EP-183642 ... 2 06/04/2018 Zimmer Biomet, Inc.
Vanguard Knee System PS Tibial Bearing, Part Number 183621 Intended for use in knee joint replac... 2 06/01/2018 Zimmer Biomet, Inc.
Biomet Modular Primary Tibial Tray Implants; Modular Interlok Primary Tray (size 75 mm); Item No. 14... 2 06/01/2018 Zimmer Biomet, Inc.
smith&nephew 5o (5 degree) GENESIS(R) II VALGUS BUSHING, REF CATALOG NUMBER 71440014 The GENESIS ... 2 05/21/2018 Smith & Nephew, Inc.
Gentle Threads, Interference Screw; Model No. 905617, for soft tissue reattachment procedures in the... 2 05/08/2018 Zimmer Biomet, Inc.
Gentle Threads, Interference Screw; Model No. 905604, for soft tissue reattachment procedures in the... 2 05/08/2018 Zimmer Biomet, Inc.
Gentle Threads, Interference Screw; Model No. 905605, for soft tissue reattachment procedures in the... 2 05/08/2018 Zimmer Biomet, Inc.
Gentle Threads, Interference Screw; Model No. 905607, for soft tissue reattachment procedures in the... 2 05/08/2018 Zimmer Biomet, Inc.
Gentle Threads, Interference Screw; Model No. 905608, for soft tissue reattachment procedures in the... 2 05/08/2018 Zimmer Biomet, Inc.
Gentle Threads, Interference Screw; Model No. 905615, for soft tissue reattachment procedures in the... 2 05/08/2018 Zimmer Biomet, Inc.
RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements... 2 05/04/2018 Mako Surgical Corporation
ATTUNE Revision CRS Femoral RT SZ 5 Cemented, Catalog No. 150440205, Femoral Revision Implant, Knee 2 04/30/2018 DePuy Orthopaedics, Inc.
ATTUNE Revision CRS Femoral LT SZ 5 Cemented, Catalog No. 150440105, Femoral Revision Implant, Knee 2 04/30/2018 DePuy Orthopaedics, Inc.
Orthopedic Salvage System (OSS) Modular Arthrodesis 0 Degree Locking Collar, Model Number CP260600 ... 2 04/25/2018 Zimmer Biomet, Inc.
Knee Prosthesis, Sterile, Single-Use devices Product Usage: The knee system devices are intended... 2 04/24/2018 Howmedica Osteonics Corp.
Triathlon Revision Knee Catalog #5545-A-301 and Catalog #5546-A-601 The knee system devices are s... 2 04/20/2018 Howmedica Osteonics Corp.
Persona Partial Knee Spacer Blocks To assist in partial knee arthroplasty surgery 2 03/28/2018 Zimmer Biomet, Inc.
Persona Partial Knee spacer block instruments; (1) 8mm block, Model Number: 42-5399-035-08; (2) 9mm ... 2 03/28/2018 Zimmer Biomet, Inc.
PERSONA® THE PERSONALIZED KNEE SYSTEM "PSN TIB STM 5 DEG SZ D R" indicated for patients with severe ... 2 03/27/2018 Zimmer Biomet, Inc.
smith&nephew, LEGION HK FEMORAL WEDGE (WEDGE AND SCREW), 5 MM, SIZE 5, REF 71422159, QTY: (1), STERI... 2 03/19/2018 Smith & Nephew, Inc.
Apex Knee System, Tibial Baseplate Size 6 Left, non-porous - KC-2206L The Apex Knee System is int... 2 03/19/2018 OMNIlife science Inc.
U2 Total Knee System Tibial Insert, Posterior Stabilized, #3, 11mm Thick Catalogue number 2303-3032... 2 03/19/2018 United Orthopedic Corporation
U2 Total Knee System Tibial Insert, PSA, #1, 21mm Thick Catalogue number 2303-5016 The U2 Total K... 2 03/19/2018 United Orthopedic Corporation

*   The maximium 500 devices meeting your search criteria returned. Please narrow your search.
 
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