|
Product Description
|
Recall Class
|
FDA Recall Posting Date
|
Recalling Firm
|
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) 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) KNEE ARTHROSCOPY CDS-LF , Pack Number CDS983874F ;
2)...
|
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 Convenience kits labeled as:
1) ECMO INSERTION BUNDLE W/O CANNULA, Pack Number CVI4915;
...
|
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.
|
BPKN15C KNEE BASIN PACK BHS- Procedure tray
Catalog Number: BPKN15C
|
2
|
07/05/2024
|
American Contract Systems Inc
|
KNEE ARTHROSCOPY PACK-Procedure Kit
Catalog Number: WEKA15B
|
2
|
07/05/2024
|
American Contract Systems Inc
|
CUSTOM KNEE - 206061-Procedure Kit
Catalog Number: UDKN68AG
|
2
|
07/05/2024
|
American Contract Systems Inc
|
CUSTOM KNEE - 206061-Procedure Kit
Catalog Number: UDKN68AE
|
2
|
07/05/2024
|
American Contract Systems Inc
|
TOTAL KNEE-Procedure Kit
Catalog Number: SMTK21C
|
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: SFTK54B
|
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 - 297835 -Procedure Kit
Catalog Number: RGTK10L
|
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 -Procedure Kit
Catalog Number: QPTK95B
|
2
|
07/05/2024
|
American Contract Systems Inc
|
TOTAL KNEE -Procedure Kit
Catalog Number: QPTK95A
|
2
|
07/05/2024
|
American Contract Systems Inc
|
KNEE ARTHROSCOPY-Procedure Kit
Catalog Number: QPKA35A
|
2
|
07/05/2024
|
American Contract Systems Inc
|
KNEE ARTHROSCOPY PACK
Catalog Number: MEKA12R
|
2
|
07/05/2024
|
American Contract Systems Inc
|
TOTAL KNEE, ST LUKES
Catalog Number: LMTK17AP
|
2
|
07/05/2024
|
American Contract Systems Inc
|
KNEE SCOPE Procedure tray
Catalog Number: COKN48L
|
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
|
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
|
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
|
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
|
RKNXC0003, RHEO KNEE XC 3 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 Ti Plasma Spray, Reference Numbers:
REF: PE25153...
|
2
|
02/29/2024
|
United Orthopedic Corporation
|
USTAR II Knee System Cemented curved stem, RHS, Non Coated for the following reference numbers:
R...
|
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: 6742-1-4...
|
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.
|
SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #11 -Intended for knee replacement
Part Numbe...
|
2
|
01/31/2024
|
Howmedica Osteonics Corp.
|
SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #5 -Intended for knee replacement
Part Number:...
|
2
|
01/31/2024
|
Howmedica Osteonics Corp.
|
SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #7 -Intended for knee replacement
Part Number:...
|
2
|
01/31/2024
|
Howmedica Osteonics Corp.
|
SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #9 -Intended for knee replacement
Part Number:...
|
2
|
01/31/2024
|
Howmedica Osteonics Corp.
|
SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #11 -Intended for knee replacement
Part Number...
|
2
|
01/31/2024
|
Howmedica Osteonics Corp.
|
SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #7 -Intended for knee replacement
Part Number: ...
|
2
|
01/31/2024
|
Howmedica Osteonics Corp.
|
SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #9 -Intended for knee replacement
Part Number:...
|
2
|
01/31/2024
|
Howmedica Osteonics Corp.
|
SCORPIO U-DOME PATELLA -Intended for knee replacement
Part Number: 73-3110
|
2
|
01/31/2024
|
Howmedica Osteonics Corp.
|
SCORPIO U-DOME PATELLA -Intended for knee replacement
Part Number: 73-3308
|
2
|
01/31/2024
|
Howmedica Osteonics Corp.
|
SCORPIO U-DOME PATELLA -Intended for knee replacement
Part Number: 73-3508
|
2
|
01/31/2024
|
Howmedica Osteonics Corp.
|
SCORPIO U-DOME PATELLA -Intended for knee replacement
Part Number: 73-3708
|
2
|
01/31/2024
|
Howmedica Osteonics Corp.
|
SCORPIO U-DOME PATELLA -Intended for knee replacement
Part Number: 73-3710
|
2
|
01/31/2024
|
Howmedica Osteonics Corp.
|
SCORPIO U-DOME PATELLA -Intended for knee replacement
Part Number: 73-3910
|
2
|
01/31/2024
|
Howmedica Osteonics Corp.
|
Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement
Part Number: 82-2-0908 ...
|
2
|
01/31/2024
|
Howmedica Osteonics Corp.
|
Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement
Part Number: 82-2-0910
...
|
2
|
01/31/2024
|
Howmedica Osteonics Corp.
|
HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT
Intended for knee replacement
Part Number...
|
2
|
01/31/2024
|
Howmedica Osteonics Corp.
|
HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT
Intended for knee replacement
Part Number: 62...
|
2
|
01/31/2024
|
Howmedica Osteonics Corp.
|
HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT
Intended for knee replacement
Part Number:...
|
2
|
01/31/2024
|
Howmedica Osteonics Corp.
|
P7 28MM 10 DEGREE +4MM INSERT Intended for knee replacement
Part Number: 6302-6-107
|
2
|
01/31/2024
|
Howmedica Osteonics Corp.
|
P7 32MM 1O DEGREE +4MM INSERT
Intended for knee replacement
Part Number: 6302-6-307
|
2
|
01/31/2024
|
Howmedica Osteonics Corp.
|
LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement
Part Number: 6637-0-028
|
2
|
01/31/2024
|
Howmedica Osteonics Corp.
|
LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT
Intended for knee replacement
Part Number: 6637-0-228
|
2
|
01/31/2024
|
Howmedica Osteonics Corp.
|
LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT
Intended for knee replacement
Part Number: 6637-0-231
|
2
|
01/31/2024
|
Howmedica Osteonics Corp.
|
LEFT X-LARGE-PCA MOD.REV.DUR.REV.INSERT
Intended for knee replacement.
Product Number: 6637-0-...
|
2
|
01/31/2024
|
Howmedica Osteonics Corp.
|
LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT
Intended for knee replacement.
Product Number: 6637-0-...
|
2
|
01/31/2024
|
Howmedica Osteonics Corp.
|
RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT
Intended for knee replacement
Product Number: 6637-...
|
2
|
01/31/2024
|
Howmedica Osteonics Corp.
|
RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT
Intended for knee replacement
Product Number: 6637-...
|
2
|
01/31/2024
|
Howmedica Osteonics Corp.
|
RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT
Intended for knee replacement.
Product Number: 6637-0...
|
2
|
01/31/2024
|
Howmedica Osteonics Corp.
|
PRIMARY REV.TIB.INSERT-DURACON
Intended for knee replacement.
Product Number: 6637-4-031
|
2
|
01/31/2024
|
Howmedica Osteonics Corp.
|