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Crédits
Devices
KNEE PACK
Modèle / numéro de série
Catalog number 002618-000 Lot numbers 000006700, 000006897
Distribution
The firm distributed to 13 hospitals and medical facilities located in CO, IN, MI, MN, MT, UT, and WA.
Description du dispositif
KNEE PACK
Manufacturer
Windstone Medical, Inc.
1 Event
Rappel de KNEE PACK
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Fabricant
Windstone Medical, Inc.
Adresse du fabricant
Windstone Medical, Inc., 1602 4th Ave North, Billings MT 59101
Source
USFDA
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Device Recall Knee Pack
Modèle / numéro de série
Lot number and expiration date 86307, 7/15/2018 86746, 8/7/2018 88245, 10/30/2018
Classification du dispositif
General and Plastic Surgery Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.
Description du dispositif
Knee Pack, part number AMS4211
Manufacturer
Windstone Medical Packaging, Inc.
Device Recall Total Knee Pack
Modèle / numéro de série
Lot number and expiration date 101282, 6/12/2018
Classification du dispositif
General and Plastic Surgery Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.
Description du dispositif
Total Knee Pack (15710), part number AMS6563
Manufacturer
Windstone Medical Packaging, Inc.
Knee PackAMS4211
Modèle / numéro de série
Lot Number/ Expiration Date: 77332 8/10/2017
Classification du dispositif
General and Plastic Surgery Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.
Description du dispositif
Knee Pack, Kit number AMS4211 || convenience custom kits used for general surgery in hospital operating room
Manufacturer
Windstone Medical Packaging, Inc.
Total Knee Pack
Modèle / numéro de série
Lot Number/ Expiration Date: 78940 9/5/2017
Classification du dispositif
General and Plastic Surgery Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.
Description du dispositif
Total Knee Pack, Kit number AMS4010(A || convenience custom kits used for general surgery in hospital operating room
Manufacturer
Windstone Medical Packaging, Inc.
CUSTOM STERILE KNEE PACK
Modèle / numéro de série
Model Catalog: SOP30KP'XXX' (Lot serial: 670843); Model Catalog: SOP30ARXXX (Lot serial: 700360); Model Catalog: SOP30KAXXX (Lot serial: 670843); Model Catalog: SOP30ARXXX (Lot serial: 670843); Model Catalog: SOP30KP'XXX' (Lot serial: 670345); Model Catalog: SOP30TKXXX (Lot serial: 670345); Model Catalog: SOP30KAXXX (Lot serial: 670345); Model Catalog: SOP30ARXXX (Lot serial: 670345); Model Catalog: SOP30ACXXX (Lot serial: 701594); Model Catalog: SOP30THXXX (Lot serial: 710742); Model Catalog: SOP30THXXX (Lot serial: 715392); Model Catalog: SOP30THXXX (Lot serial: 684544); Model Catalog: SOP30THXXX (Lot serial: 678929); Model Catalog: SOP30LEXXX (Lot serial: 714615); Model Catalog: SOP30LEXXX (Lot serial: 702865); Model Catalog: SOP30LEXXX (Lot serial: 696918); Model Catalog: SOP30TKXXX (Lot serial: 670843); Model Catalog: SOP30KP'XXX' (Lot serial: 660207); Model Catalog: SOP30TKXXX (Lot serial: 660207); Model Catalog: SOP30KAXXX (Lot serial: 660207); Model Catalog: SOP30ARXXX (Lot serial: 660207); Model Cat
Description du dispositif
STERILE SURGICAL/ARTHROSCOPIC PACK
Manufacturer
CARDINAL HEALTH CANADA INC.
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