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U.S. Department of Health and Human Services

Medical Device Recalls
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Kendall SCD Blended Comfort Sleeves Knee Length Small - For use with Kendall SCD SmartFlow SKU 8... 2 06/06/2025 Cardinal Health 200, LLC
Kendall SCD Comfort Sleeves Knee Length Small, Pediatric - For use with Kendall SCD SmartFlow, SK... 2 06/06/2025 Cardinal Health 200, LLC
SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kenda... 2 06/06/2025 Cardinal Health 200, LLC
LOWER EXTREMITY, Model: NCEX20I; LOWER EXTREMITY, Model: NCEX20J; TOTAL KNEE PACK, Model: NCTK31K... 2 06/06/2025 American Contract Systems, Inc.
Medline procedure kits labeled as: 1) ACL ARTHROSCOPY PACK, Pack Number DYNJ55316G; 2) ARTERIOGRA... 2 03/26/2025 MEDLINE INDUSTRIES, LP - Northfield
Medline procedure kits labeled as: 1) AV FISTULA PACK-LF, Pack Number DYNJ0826753O; 2) BARRINGT... 2 03/25/2025 MEDLINE INDUSTRIES, LP - Northfield
Medline procedure kits labeled as: 1) A & A KNEE PACK-LF, Pack Number DYNJHS0136D; 2) ABD CLOSURE... 2 03/25/2025 MEDLINE INDUSTRIES, LP - Northfield
Medline procedure kits labeled as: 1) ARTHROSCOPY PACK, Pack Number DYNJHS0101I; 2) ARTHROSCOPY... 2 03/25/2025 MEDLINE INDUSTRIES, LP - Northfield
NexGen LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented pros... 2 03/24/2025 Zimmer, Inc.
Proxima Drape labeled as ORTHO TRAUMA CDS, TOTAL KNEE AUX PACK, TOTAL HIP PACK, TOTAL HIP, TOTAL KNE... 2 03/14/2025 MEDLINE INDUSTRIES, LP - Northfield
EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705; EMPOWR 3D Knee Tibial Insert, 3R 14MM, ... 2 12/26/2024 Encore Medical, LP
EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706 2 12/23/2024 Encore Medical, LP
MISHA Knee System Implant Small, Left, REF: 2-1001. MISHA Knee System Implant Small, Right, REF: ... 2 12/23/2024 Moximed, Inc.
EVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZE 5 RIGHT PRIMARY, REF: EFSRP5PR; EVOLUTION MP FEM... 2 12/18/2024 MicroPort Orthopedics Inc.
MEDLINE convenience kits labeled as: 1) LAKELAND SINGLE BASIN PACK-LF, REF DYNJ0619907I; 2) LAK... 2 12/05/2024 MEDLINE INDUSTRIES, LP - Northfield
MEDLINE convenience kits labeled as: 1) ORTHO LAMINECTOMY-LF, REF CDS780112J; 2) NEURO CRANIOTOMY... 2 12/05/2024 MEDLINE INDUSTRIES, LP - Northfield
Halyard KNEE ARTHROSCOPY PACK - Medical convenience kits Model Number: MAMC204-16 2 11/14/2024 AVID Medical, Inc.
Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: EUOR002-06 2 11/14/2024 AVID Medical, Inc.
Halyard TOTAL KNEE - Medical convenience kits Model Number: GRND008-09 2 11/14/2024 AVID Medical, Inc.
Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: EUOR002-05 2 11/14/2024 AVID Medical, Inc.
Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: ESJH012-07 2 11/14/2024 AVID Medical, Inc.
smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT, REF 71421015;... 2 10/31/2024 Smith & Nephew Inc
smith&nephew LEGION OXINIUM POSTERIOR STABILIZED NONPOROUS FEMORAL COMPONENT, SIZE 5N, RIGHT, NARROW... 2 10/31/2024 Smith & Nephew Inc
smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 4 LEFT, REF 71421164; PROS... 2 10/30/2024 Smith & Nephew Inc
smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 3 LEFT, REF 71421163; PROS... 2 10/30/2024 Smith & Nephew Inc
Medline brand medical procedure convenience kits, labeled as: 1) NEW LONDON TOTAL KNEE CDS, REF C... 2 10/23/2024 MEDLINE INDUSTRIES, LP - Northfield
Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable device intended for cemen... 2 10/07/2024 Howmedica Osteonics Corp.
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) LAMINECTOMY CD... 2 09/11/2024 MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits, labeled as: 1) KNEE ARTHROSCOPY CDS-LF , Pack Number CDS983874F ; 2)... 2 09/06/2024 MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits labeled as: 1) ARTHROGRAPHY DRAPE PACK , Pack Number 00-399027M ; 2) ART... 2 09/06/2024 MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits labeled as: 1) SPECIAL PROCEDURE PACK ARTERI , Pack Number 00-399024X ; ... 2 09/06/2024 MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits labeled as: 1) ECMO INSERTION BUNDLE W/O CANNULA, Pack Number CVI4915; ... 2 09/06/2024 MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits labeled as: 1) GER ARTH BASIN PK RFID-LF , Pack Number DYNJ0100999K ; 2)... 2 09/06/2024 MEDLINE INDUSTRIES, LP - Northfield
Medline procedural kits labeled as: 1) AFCH ANTERIOR SEGMENT PK, Pack Number DYNJ63330B ; 2) AN... 2 08/28/2024 MEDLINE INDUSTRIES, LP - Northfield
Medline medical procedure kits labeled as follows: a) ARTHROSCOPY, REF DYNJ909699; b) BACK CDS,... 2 08/22/2024 MEDLINE INDUSTRIES, LP - Northfield
American Contract Systems Extremity convenience kit, American Contract Systems Hand Pack convenience... 2 08/07/2024 American Contract Systems, Inc.
LINK SymphoKnee Patella Sizing Template, Item Number 881-509/00 2 07/25/2024 LINK BIO CORP
Endo Model M Tibial Components Modular Knee Prosthesis System. Product codes 15-2814/01, 15-2814/02... 2 07/18/2024 Waldemar Link GmbH & Co. KG (Mfg Site)
Nitro Glide Knee Walker-offers users recovering from a below-the-knee injury the ability to remain m... 2 07/12/2024 Medical Depot Inc.
Nitro Glide Knee Walker-offers users recovering from a below-the-knee injury the ability to remain m... 2 07/12/2024 Medical Depot Inc.
TOTAL KNEE - 302497- Procedure tray Catalog Number: ANTK12AF 2 07/05/2024 American Contract Systems Inc
MAJOR KNEE - 302497- Procedure tray Catalog Number: ASKN23B 2 07/05/2024 American Contract Systems Inc
TOTAL KNEE - 247546 - Procedure tray Catalog Number: BFTK01AA 2 07/05/2024 American Contract Systems Inc
TOTAL KNEE - 247546 Procedure tray Catalog Number: BFTK01Z 2 07/05/2024 American Contract Systems Inc
ARTHO KNEE BAPTIST SOUTH PACK Procedure tray Catalog Number: BPKA49B 2 07/05/2024 American Contract Systems Inc
ARTHRO KNEE BEACHES PACK BHS- Procedure tray Catalog Number: BPKB46B 2 07/05/2024 American Contract Systems Inc
BPKN15C KNEE BASIN PACK BHS- Procedure tray Catalog Number: BPKN15C 2 07/05/2024 American Contract Systems Inc
KNEE SCOPE Procedure tray Catalog Number: COKN48L 2 07/05/2024 American Contract Systems Inc
TOTAL KNEE, ST LUKES Catalog Number: LMTK17AP 2 07/05/2024 American Contract Systems Inc
KNEE ARTHROSCOPY PACK Catalog Number: MEKA12R 2 07/05/2024 American Contract Systems Inc
KNEE ARTHROSCOPY-Procedure Kit Catalog Number: QPKA35A 2 07/05/2024 American Contract Systems Inc
TOTAL KNEE -Procedure Kit Catalog Number: QPTK95A 2 07/05/2024 American Contract Systems Inc
TOTAL KNEE -Procedure Kit Catalog Number: QPTK95B 2 07/05/2024 American Contract Systems Inc
TOTAL KNEE - 297835-Procedure Kit Catalog Number: RGTK10K 2 07/05/2024 American Contract Systems Inc
TOTAL KNEE - 297835 -Procedure Kit Catalog Number: RGTK10L 2 07/05/2024 American Contract Systems Inc
KNEE ARTHROSCOPY PACK-Procedure Kit Catalog Number: SFAR60A 2 07/05/2024 American Contract Systems Inc
TOTAL KNEE-Procedure Kit Catalog Number: SFTK54B 2 07/05/2024 American Contract Systems Inc
KNEE ARTHROSCOPY-Procedure Kit Catalog Number: SLAR14G 2 07/05/2024 American Contract Systems Inc
TOTAL KNEE-Procedure Kit Catalog Number: SMTK21C 2 07/05/2024 American Contract Systems Inc
CUSTOM KNEE - 206061-Procedure Kit Catalog Number: UDKN68AE 2 07/05/2024 American Contract Systems Inc
CUSTOM KNEE - 206061-Procedure Kit Catalog Number: UDKN68AG 2 07/05/2024 American Contract Systems Inc
KNEE ARTHROSCOPY PACK-Procedure Kit Catalog Number: WEKA15B 2 07/05/2024 American Contract Systems Inc
EVOLUTION® MP Femoral CS/CR Non-Porous Non-porous MicroPort total knee replacement implants are f... 2 07/01/2024 MicroPort Orthopedics Inc.
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3... 2 05/28/2024 Stryker Orthopaedics
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3... 2 05/28/2024 Stryker Orthopaedics
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3... 2 05/28/2024 Stryker Orthopaedics
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3... 2 05/28/2024 Stryker Orthopaedics
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3... 2 05/28/2024 Stryker Orthopaedics
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3... 2 05/28/2024 Stryker Orthopaedics
RKNXC0005, RHEO KNEE XC 5 YR WARRANTY, MD, CE, External lower limb prosthetic component 2 05/10/2024 Ossur H / F
RKNXC0003, RHEO KNEE XC 3 YR WARRANTY, MD, CE, External lower limb prosthetic component 2 05/10/2024 Ossur H / F
RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic component 2 05/10/2024 Ossur H / F
RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component 2 05/10/2024 Ossur H / F
Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 189082. The product ... 2 04/22/2024 Biomet, Inc.
ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE T... 2 03/29/2024 DePuy Orthopaedics, Inc.
Assembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument Set, used with the TMINI... 2 03/20/2024 Think Surgical, Inc.
USTAR II Knee System Cemented curved stem, RHS, Non Coated for the following reference numbers: R... 2 02/29/2024 United Orthopedic Corporation
USTAR II Knee System : Cemented Curved Stem, RHS Ti Plasma Spray, Reference Numbers: REF: PE25153... 2 02/29/2024 United Orthopedic Corporation
Medline Kits, trays, and packs labeled as follows: a) ANTERIOR PACK, REF DYNJ64814A; b) ARTHROG... 1 02/25/2024 MEDLINE INDUSTRIES, LP - Northfield
PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1... 2 01/31/2024 Howmedica Osteonics Corp.
PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-... 2 01/31/2024 Howmedica Osteonics Corp.
PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-4... 2 01/31/2024 Howmedica Osteonics Corp.
TIBIAL BEARING INSERT SERIES P-S I ASSY Intended for knee replacement Product Number: 7291... 2 01/31/2024 Howmedica Osteonics Corp.
SCORPIO RECESSED PATELLA- Intended for Knee Replacement Part Number: 3044-0026 2 01/31/2024 Howmedica Osteonics Corp.
SCORPIO RECESSED PATELLA- Intended for knee replacement Part Number: 3044-0028 2 01/31/2024 Howmedica Osteonics Corp.
SCORPIO RECESSED PATELLA- Intended for knee replacement Part Number: 3044-0030 2 01/31/2024 Howmedica Osteonics Corp.
SCORPIO RECESSED PATELLA-Intended for knee repalcment Part Number: 3044-0032 2 01/31/2024 Howmedica Osteonics Corp.
SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052-0515 2 01/31/2024 Howmedica Osteonics Corp.
SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052-0524 2 01/31/2024 Howmedica Osteonics Corp.
SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0321 2 01/31/2024 Howmedica Osteonics Corp.
SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0510 2 01/31/2024 Howmedica Osteonics Corp.
SCORPIO TS TIB INSERT-Intended for knee replacement Part Number:72-4-7512 2 01/31/2024 Howmedica Osteonics Corp.
SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7514 2 01/31/2024 Howmedica Osteonics Corp.
SCORPIO TS TIB INSERT -Intended for knee replacment Part Number: 72-4-7516 2 01/31/2024 Howmedica Osteonics Corp.
SCORPIO TS TIB INSERT. Intended for knee replacement Part Number: 72-4-7518 2 01/31/2024 Howmedica Osteonics Corp.
SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7521 2 01/31/2024 Howmedica Osteonics Corp.
SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7524 2 01/31/2024 Howmedica Osteonics Corp.
Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- Intended for knee replacement Part Number: 72-15-0324 2 01/31/2024 Howmedica Osteonics Corp.
Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-... 2 01/31/2024 Howmedica Osteonics Corp.
Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-... 2 01/31/2024 Howmedica Osteonics Corp.

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