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U.S. Department of Health and Human Services

Medical Device Recalls
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Product: kne
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EMPOWR Partial Knee Peg Drill; Model: 800-06-008. 2 11/20/2020 Encore Medical, LP
EMPOWR Partial Knee Peg Drill Guide; Model: 800-06-007. 2 11/20/2020 Encore Medical, LP
Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 a... 2 11/19/2020 Mako Surgical Corporation
OsteoBridge Intremedullary Knee Arthrodesis (IKA) nails 2 11/06/2020 Merete Medical GmbH
DJO EMPOWR Tibial Knee Punch Handle Part No. 801-05-040 and 801-05-018 contained in Instrument Tray ... 2 10/07/2020 Encore Medical, LP
PROTEXIS Latex Micro Surgical Gloves Size 5.5 - Product Usage: This surgeon s glove is a disposable ... 2 08/28/2020 Cardinal Health 200, LLC
PROTEXIS Latex Micro Surgical Gloves Size 6.0 - Product Usage: This surgeon s glove is a disposable ... 2 08/28/2020 Cardinal Health 200, LLC
PROTEXIS Latex Micro Surgical Gloves Size 6.5 - Product Usage: This surgeon s glove is a disposable ... 2 08/28/2020 Cardinal Health 200, LLC
PROTEXIS Latex Micro Surgical Gloves Size 7.0 - Product Usage: This surgeon s glove is a disposable ... 2 08/28/2020 Cardinal Health 200, LLC
PROTEXIS Latex Micro Surgical Gloves Size 8.0 - Product Usage: This surgeon s glove is a disposable ... 2 08/28/2020 Cardinal Health 200, LLC
PROTEXIS Latex Micro Surgical Gloves Size 8.5 - Product Usage: This surgeon s glove is a disposable ... 2 08/28/2020 Cardinal Health 200, LLC
PROTEXIS Latex Micro Surgical Gloves Size 9.0 - Product Usage: This surgeon s glove is a disposable ... 2 08/28/2020 Cardinal Health 200, LLC
PROTEXIS Latex Micro Surgical Gloves Size 7.5 - Product Usage: This surgeon s glove is a disposable ... 2 08/28/2020 Cardinal Health 200, LLC
Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat: TCR-121-1... 2 08/22/2020 Conformis, Inc.
Tibial knee prosthesis 2 08/08/2020 Smith & Nephew, Inc.
Cardinal Health NPWT Occlusion Detection Canister 300cc, Prescription Only - Product Usage: The syst... 2 07/10/2020 Cardinal Health 200, LLC
Cardinal Health NPWT Canister with Gel 300cc, Prescription Only - Product Usage: The systems are i... 2 07/10/2020 Cardinal Health 200, LLC
Mueller Sports Medicine Hybrid Wraparound Knee Support, Qty: 1 unit per box 2 06/30/2020 Mueller Sports Medicine, Inc
Knee Products: 183622 Vanguard Knee System PS Tibial Bearing, 12 MM X 63/67 MM 183620 Vanguard Kne... 2 05/28/2020 Biomet, Inc.
Knee Products: 155308 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 65 MM 155326 Knees... 2 05/28/2020 Biomet, Inc.
Knee Products: 154335 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D... 2 05/28/2020 Biomet, Inc.
Knee Products: 150414 Orthopedic Salvage System (OSS) Tibial Bearing, 20 MM Standard - Product Usa... 2 05/28/2020 Biomet, Inc.
Knee Products: 141356 Regenerex Series-A Patella 3 Peg, 31 MM 141358 Regenerex Series-A Patella 3 ... 2 05/28/2020 Biomet, Inc.
Knee Products: 189260 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 MM X 71 MM 189720 Va... 2 05/28/2020 Biomet, Inc.
Knee Products: TMJPM-1510 Microfixation Custom Made Device, Left PM-TMJ Model (01)00841036226534... 2 05/28/2020 Biomet, Inc.
Knee Products: US154709 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Le... 2 05/28/2020 Biomet, Inc.
Knee Products: 184762 Knees Vanguard Knee System, Series-A Standard Patella, 28 MM; 184764 Knees... 2 05/28/2020 Biomet, Inc.
Knee Products: 183742 Vanguard Knee System, PS+ Tibial Bearing, 12 MM, 71/75 MM EP-18360... 2 05/28/2020 Biomet, Inc.
Knee Products: 189420 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 63 MM 189422 Vang... 2 05/28/2020 Biomet, Inc.
BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175. 2 04/03/2020 Biomet, Inc.
BIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 433170. 2 04/03/2020 Biomet, Inc.
BIOMET StageOne Knee Tibial Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 433165. 2 04/03/2020 Biomet, Inc.
BIOMET StageOne Knee Femoral Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 432175. 2 04/03/2020 Biomet, Inc.
BIOMET StageOne Knee Tibial Cement Spacer Mold, 80 MM, Silicone, Sterile, Item 433180. 2 04/03/2020 Biomet, Inc.
BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165. 2 04/03/2020 Biomet, Inc.
BIOMET StageOne Knee Femoral Cement Spacer Mold, 60 MM, Silicone, Sterile, Item 432160. 2 04/03/2020 Biomet, Inc.
BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170. 2 04/03/2020 Biomet, Inc.
iTotal CR Knee Replacement System, Model No. TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LE... 2 04/01/2020 Conformis, Inc.
iTotal PS Knee Replacement System, Model No. TPS-111-1111-010101, (ITOTAL PS IPOLY IMPLANT KIT LEFT)... 2 04/01/2020 Conformis, Inc.
COLUMBUS CR/PS TIB.PLAT.PLASMAPORE, Knee implant components, various sizes, model nos. NN081K NN08... 2 03/13/2020 Aesculap Implant Systems LLC
Columbus R/PS TIB.PLATEAU Cemented, various sizes, Knee implant components, model nos. NN058K NN070... 2 03/13/2020 Aesculap Implant Systems LLC
COLUMBUS CRA/PSA TIB.PLAT.CEMENTED, Knee implant components, various sizes, model nos. NN469K NN47... 2 03/13/2020 Aesculap Implant Systems LLC
AS COLUMBUS CR/PS TIB.PLAT.CEMENTED,Knee implant components, various sizes, model nos. NN058Z NN0... 2 03/13/2020 Aesculap Implant Systems LLC
COLUMBUS REV F TIBIA OFFSET CEMENTED, Knee implant components, various sizes, model nos. NR068K NR... 2 03/13/2020 Aesculap Implant Systems LLC
Gentell Hydrogel Ag 4oz. Tube, model no. - Product Usage: Under the care of a healthcare professiona... 2 03/05/2020 Gentell, Inc
Gentell Hydrogel Ag 2x2, model no GEN-11220 - Product Usage: Under the care of a healthcare professi... 2 03/05/2020 Gentell, Inc
Gentell Hydrogel Ag 4x4, model no. GEN-11420 - Product Usage: Under the care of a healthcare profess... 2 03/05/2020 Gentell, Inc
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.

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