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Sources: EU EUDAMED, US FDA
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Flower Drill Bit Kit 2.7mm- The Drill Bit Kit, 2.7mm (DBK 027) is intended to be used with solid 2.7mm screws and can be used with any the Flower Small and Medium Implant Set Flower Ankle Plating Set , Flower Rear Foot/Calcaneus Plating Set or Flower Upper Extremity Plating Set and uses the medium locking mechanism. Catalog Number: DBK 027
FDA Recall
Terminated
·Flower Orthopedics Corporation·Product code HTW·September 1, 2021
Flower Drill Bit Kit 2.4 mm-intended to be used with solid 2.4mm screws and can be used with any plate as part of the Flower Small and Medium Implant Set and uses the small locking mechanism. Catalog Number: DBK 024
FDA Recall
Terminated
·Flower Orthopedics Corporation·Product code HTW·September 1, 2021
Flower Drill Bit Kit 2.0 mm - intended to be used with solid 2.0mm screws and can be used with any plate that has been cleared as part of the Flower Small and Medium Implant Set and uses the small locking mechanism. mechanism. Catalog Number: DBK 020 2013002721
FDA Recall
Terminated
·Flower Orthopedics Corporation·Product code HTW·September 1, 2021
Flower Lag Screw Kit 2.7 mm-intended to be used with 2.7mm lag screws and can be used with any plate that as part of the Flower Small and Medium Implant Set, Flower Ankle Plating Set , Flower Rear Foot/Calcaneus Plating Set , or Flower Upper Extremity Plating Set and uses the medium locking mechanism. Catalog Number: LSK 027
FDA Recall
Terminated
·Flower Orthopedics Corporation·Product code HTW·September 1, 2021
Ti-Magna Fx Washer Ti-Versa-FXII Femoral Fixation System S/C Plates The compression tube/plates of this trauma system are used with Ti-Versa-Fx II Femoral Fixation System lag screws for the internal fixation of proximal femoral and supracondylar fractures. The Ti-Magna Fx System is an osteosynthesis item for orthopedic use in open internal fixation of fractures of the femoral neck, condyle, or tibia, etc. The washer prevents the screw head from being buried in the bone.
FDA Recall
Terminated
·Zimmer, Inc.·Product code NDG·August 28, 2013
ZVplasty, 10G, 10mm Double Balloon Kit, REF VCF-1010-DBK. For use in Orthopedic / spinal procedures.
FDA Recall
Terminated
·Zavation·Product code NDN·March 25, 2021
Syneture Sofsilk 3/0 BK 12X18" PRE-CUT WAX-RACE non-absorbable braided nylon sutures S194 Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic, microsurgery and neurological surgery
FDA Recall
Terminated
·Product code GAP·June 3, 2011
Single-use sterile puncture attachment UA1256-U used with the BK Medical Ultrasounds: Diagnostic Ultrasound scanner Pro Focus 2202 and Diagnostic Ultrasound Transducer 8667 Diagnostic Ultrasound scanner 2102 and Diagnostic Ultrasound Transducer 8667 Diagnostic Ultrasound scanner 2101 and Diagnostic Ultrasound Transducer 8667 Performing ultrasound guided biopsies of the prostate.
FDA Recall
Terminated
·Bk Medical Mileparken 34 Iierlev Denmark·September 8, 2008
DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.
FDA Recall
Open, Classified
·Beckman Coulter Mishima K.K. 454-32 Higashino; Nagaizumi-Cho Sunto-Gun Japan·Product code JJE·July 10, 2024
Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 - 179433670
FDA Recall
Open, Classified
·Beckman Coulter Mishima K.K. 454-32 Higashino; Nagaizumi-Cho Sunto-Gun Japan·Product code JJE·April 30, 2025
Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 - 179433670
FDA Recall
Open, Classified
·Beckman Coulter Mishima K.K. 454-32 Higashino; Nagaizumi-Cho Sunto-Gun Japan·Product code CKB·April 30, 2025
DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.
FDA Recall
Open, Classified
·Beckman Coulter Mishima K.K. 454-32 Higashino; Nagaizumi-Cho Sunto-Gun Japan·Product code JJE·June 5, 2024
bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66.
FDA Recall
Open, Classified
·B-K Medical A/S Mileparken 34 Herlev Denmark·Product code IYN·November 30, 2023
bk3500 Ultrasound System w/battery; Model No. 2300-41; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Recall
Open, Classified
·B-K Medical A/S Mileparken 34 Herlev Denmark·Product code IYN·October 9, 2025
bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Recall
Open, Classified
·B-K Medical A/S Mileparken 34 Herlev Denmark·Product code IYN·October 9, 2025
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Recall
Open, Classified
·B-K Medical A/S Mileparken 34 Herlev Denmark·Product code IYN·October 9, 2025
bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and bkActive 2300, model #2300-66, ultrasound system with battery option.
FDA Recall
Open, Classified
·B-K Medical A/S Mileparken 34 Herlev Denmark·Product code IYN·September 4, 2024
bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Recall
Open, Classified
·B-K Medical A/S Mileparken 34 Herlev Denmark·Product code IYN·October 9, 2025
UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Recall
Open, Classified
·B-K Medical A/S Mileparken 34 Herlev Denmark·Product code IYN·October 9, 2025
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Recall
Open, Classified
·B-K Medical A/S Mileparken 34 Herlev Denmark·Product code IYN·October 9, 2025