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Product Description
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Recall
Class
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FDA Recall
Posting Date
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Recalling Firm
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Endo Model Knee Fusion Nail SK, Knee Fusion
Nail, Coupling Component, right, modular, L= 68 mm, Tap...
|
2
|
12/09/2025
|
Waldemar Link GmbH & Co. KG (Mfg Site)
|
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MEDLINE convenience kits labeled as:
1) NEURO CRANIOTOMY CDS #36-RF, REF CDS780119V;
2) BASIC B...
|
2
|
11/14/2025
|
Medline Industries, LP
|
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MEDLINE convenience kits labeled as:
1) GENERAL LAPAROSCOPY, REF CDS930027W;
2) GENERAL MAJOR C...
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2
|
11/14/2025
|
Medline Industries, LP
|
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Medical convenience kits
Item Number/Description
ANSH14AF SHOULDER PACK - 205962
EVAH76H ANTER...
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2
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10/16/2025
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American Contract Systems Inc.
|
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LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed. ...
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2
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09/08/2025
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Waldemar Link GmbH & Co. KG (Mfg Site)
|
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Brand Name: HOMEDICS
Product Name: Air Compression Leg Massager
Model/Catalog Number: SR-160HJ
Pr...
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2
|
08/28/2025
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Zhejiang Luyao Electronics Technology Co., Ltd.
|
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AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as:
1) ANTERIOR HIP PACK, MOD...
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2
|
08/28/2025
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American Contract Systems Inc
|
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Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS
Product Name: EMPOWR 3D KNEETM INS, 7R 16MM, VE
...
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2
|
08/08/2025
|
Encore Medical, LP
|
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Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS
Product Name: EMPOWR 3D KNEETM INS, 4L 16MM, VE
...
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2
|
08/08/2025
|
Encore Medical, LP
|
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Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS
Product Name: EMPOWR 3D KNEETM INS, 11L 12MM, VE
...
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2
|
07/17/2025
|
Encore Medical, LP
|
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Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS
Product Name: EMPOWR 3D KNEETM INS, 11L 10MM, VE
...
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2
|
07/17/2025
|
Encore Medical, LP
|
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Brand Name: Canturio® Smart Extension
Product Name: CSE Implant
Model/Catalog Number: 43-5570-030-...
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2
|
07/08/2025
|
Canary Medical, Inc.
|
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Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-5013...
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2
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07/02/2025
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CORIN MEDICAL, LTD.
|
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Kendall SCD Comfort Sleeves
Knee Length Small, Pediatric -
For use with Kendall SCD
SmartFlow, SK...
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2
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06/06/2025
|
Cardinal Health 200, LLC
|
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SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kenda...
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2
|
06/06/2025
|
Cardinal Health 200, LLC
|
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Kendall SCD Blended Comfort
Sleeves Knee Length Small -
For use with Kendall SCD
SmartFlow
SKU 8...
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2
|
06/06/2025
|
Cardinal Health 200, LLC
|
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LOWER EXTREMITY, Model: NCEX20I;
LOWER EXTREMITY, Model: NCEX20J;
TOTAL KNEE PACK, Model: NCTK31K...
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2
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06/06/2025
|
American Contract Systems, Inc.
|
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Medline procedure kits labeled as:
1) ACL ARTHROSCOPY PACK, Pack Number DYNJ55316G;
2) ARTERIOGRA...
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2
|
03/26/2025
|
MEDLINE INDUSTRIES, LP - Northfield
|
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Medline procedure kits labeled as:
1) ARTHROSCOPY PACK, Pack Number DYNJHS0101I;
2) ARTHROSCOPY...
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2
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03/25/2025
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MEDLINE INDUSTRIES, LP - Northfield
|
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Medline procedure kits labeled as:
1) A & A KNEE PACK-LF, Pack Number DYNJHS0136D;
2) ABD CLOSURE...
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2
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03/25/2025
|
MEDLINE INDUSTRIES, LP - Northfield
|
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Medline procedure kits labeled as:
1) AV FISTULA PACK-LF, Pack Number DYNJ0826753O;
2) BARRINGT...
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2
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03/25/2025
|
MEDLINE INDUSTRIES, LP - Northfield
|
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NexGen LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented pros...
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2
|
03/24/2025
|
Zimmer, Inc.
|
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Proxima Drape labeled as ORTHO TRAUMA CDS, TOTAL KNEE AUX PACK, TOTAL HIP PACK, TOTAL HIP, TOTAL KNE...
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2
|
03/14/2025
|
MEDLINE INDUSTRIES, LP - Northfield
|
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EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705;
EMPOWR 3D Knee Tibial Insert, 3R 14MM, ...
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2
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12/26/2024
|
Encore Medical, LP
|
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EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706
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2
|
12/23/2024
|
Encore Medical, LP
|
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MISHA Knee System Implant Small, Left, REF: 2-1001.
MISHA Knee System Implant Small, Right, REF: ...
|
2
|
12/23/2024
|
Moximed, Inc.
|
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EVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZE 5 RIGHT PRIMARY, REF: EFSRP5PR;
EVOLUTION MP FEM...
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2
|
12/18/2024
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MicroPort Orthopedics Inc.
|
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MEDLINE convenience kits labeled as:
1) LAKELAND SINGLE BASIN PACK-LF, REF DYNJ0619907I;
2) LAK...
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2
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12/05/2024
|
MEDLINE INDUSTRIES, LP - Northfield
|
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MEDLINE convenience kits labeled as:
1) ORTHO LAMINECTOMY-LF, REF CDS780112J;
2) NEURO CRANIOTOMY...
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2
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12/05/2024
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MEDLINE INDUSTRIES, LP - Northfield
|
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Halyard KNEE ARTHROSCOPY PACK - Medical convenience kits
Model Number: MAMC204-16
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2
|
11/14/2024
|
AVID Medical, Inc.
|
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Halyard KIT, TOTAL KNEE - Medical convenience kits
Model Number: EUOR002-06
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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.
|
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smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT, REF 71421015;...
|
2
|
10/31/2024
|
Smith & Nephew Inc
|
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smith&nephew LEGION OXINIUM POSTERIOR STABILIZED NONPOROUS FEMORAL COMPONENT, SIZE 5N, RIGHT, NARROW...
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2
|
10/31/2024
|
Smith & Nephew Inc
|
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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
|
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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.
|
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