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High RiskFDA
Skeletal Kinetics, Llc
EXACTECH OSSILIX FIL (MX), 5CC. Product Number: 660-02-05, UDI: 813845021006 - Product Usage: Callos is indicated to fill bony voids or ...
Surgical Devices·217 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
CRANIOSCULPT, CMF IMPACT, 3CC Product Number: C-CMF3CC, UDI: 813845020931 - Product Usage: Callos is indicated to fill bony voids or gap...
Surgical Devices·27 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
SKAFFOLD FLOW, 10CC. Product Number: SKMX-FL10, UDI: 813845020900 - Product Usage: Callos is indicated to fill bony voids or gaps of the...
Surgical Devices·54 affected·Apr 6, 2020
High RiskFDA
Philips North America, Llc
Philips Brilliance iCT SP Computed Tomography X-Ray System; Model # 728311
Medical Devices·2 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
CRANIOSCULPT, CMF IMPACT, 10CC, Product Number: C-CMF10CC, UDI: 813845020955 - Product Usage: Callos is indicated to fill bony voids or ...
Surgical Devices·51 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
CRANIOSCULPT FLOW, 3CC. Product Number: C-FLOW3CC, UDI: 813845020320 - - Product Usage: Callos is indicated to fill bony voids or gaps o...
Surgical Devices·70 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
SKAFFOLD FLOW (MX) 5CC. Product Number: SKMX-FL05, UDI: 813845020894 - Product Usage: Callos is indicated to fill bony voids or gaps of ...
Surgical Devices·41 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
CRANIOSCULPT FLOW, CAN, 10CC, Product Number: C-FLOW10CC-CAN, UDI: 813845020375 - Product Usage: Callos is indicated to fill bony voids ...
Surgical Devices·10 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
OSTEOVATION IMPACT 10CC and OSTEOVATION, 10CC, IMPACT FORMULA, Product Number: 390-2110, UDI: 813845020092 - Product Usage: Callos is in...
Surgical Devices·661 affected·Apr 6, 2020
High RiskFDA
Philips North America, Llc
Philips Brilliance iCT Computed Tomography X-Ray System; Model # 728306; UDI #s (01)00884838059474(21)100783, (01)00884838059474(21)100848
Medical Devices·19 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
OSTEOVATION RMX 5CC. Product Number: 390-6001, UDI: 813845021082 - Product Usage: Callos is indicated to fill bony voids or gaps of the ...
Surgical Devices·111 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
ACUMED CALLOS INJECT 10CC. Product Number: 65-0010-S, UDI: 813845020245 - Product Usage: Callos is indicated to fill bony voids or gaps ...
Surgical Devices·379 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
ACUMED CALLOS INJECT 3CC. Product Number: 65-0003-S, UDI: 813845020221 - Product Usage: Callos is indicated to fill bony voids or gaps ...
Surgical Devices·184 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
SKAFFOLD CMF IMPRESS (MP), 5CC. Product Number: CMMP-IM05, UDI: 813845020689 - Product Usage: Callos is indicated to fill bony voids or ...
Surgical Devices·4 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
SKAFFOLD FLOW, 3CC and SKAFFOLD FLOW (MX) 3CC. Product Number: SKMX-FL03, UDI: 813845020887 - Product Usage: Callos is indicated to fill...
Surgical Devices·29 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
OSTEOVATION, 10CC, INJECT FORMULA. Product Number: 390-2010, UDI: 813845020061 - Product Usage: Callos is indicated to fill bony voids o...
Surgical Devices·116 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
CRANIOSCULPT C, 5CC. Product Number: C-C5CC, UDI: 813845021112 - - Product Usage: Callos is indicated to fill bony voids or gaps of the ...
Surgical Devices·263 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
OSTEOVATIONEX 2CC INJECT FORMULA. Product Number: 390-0002, UDI: 813845020009 - Product Usage: Callos is indicated to fill bony voids or...
Surgical Devices·35 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
CRANIOSCULPT C, 3CC. Product Number: C-C3CC, UDI: 813845021105 - Product Usage: Callos is indicated to fill bony voids or gaps of the sk...
Surgical Devices·48 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
CRANIOSCULPT C, 10CC. Product Number: C-C10CC, UDI: 813845021129 - Product Usage: Callos is indicated to fill bony voids or gaps of the ...
Surgical Devices·307 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
CRANIOSCULPT FLOW, OUS, 5CC Product Number: C-FLOW5CC-OUS, UDI: 813845020351 - Product Usage: Callos is indicated to fill bony voids or ...
Surgical Devices·35 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
MEDTRONIC BONE VOID FILLER, SMALL. Product Number: C07A, UDI: 813845020504 - Product Usage: Callos is indicated to fill bony voids or ga...
Surgical Devices·491 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
CRANIOSCULPT, CMF IMPACT, 5CC, Product Number: C-CMF5CC, UDI: 813845020948 - Product Usage: Callos is indicated to fill bony voids or ga...
Surgical Devices·32 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
CRANIOSCULPT, FLOW 5CC. Product Number: C-FLOW5CC, UDI: 813845020337 - Product Usage: Callos is indicated to fill bony voids or gaps of ...
Surgical Devices·125 affected·Apr 6, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
System AXIOM Aristos FX - Product Usage: A dedicated x-ray system with a flat panel detector which allows the acquisition of x-ray exposu...
Medical Devices·314 affected·Apr 6, 2020
High RiskFDA
Golden State Medical Supply Inc.
Losartan Potassium Tablets, USP, 25 mg, Rx only, a) 30 ct. (NDC 60429-316-30) b) 90ct. (NDC 60429-316-90) c) 1,000 ct. (60429-316-10) bot...
Oral Drugs·0 affected·Apr 3, 2020
CriticalFDA
Heartware, Inc.
Heartware HVAD Pump Implant Kit, Product (REF) Number 1103
Medical Implants·2,614 affected·Apr 3, 2020
High RiskFDA
Philips North America, Llc
Philips Azurion 7 M20 -XperGuide Software hosted in Interventional Workspot 1.5 when used with the Azurion R2.0 system Intervent...
Medical Devices·22 affected·Apr 3, 2020
High RiskFDA
Skeletal Kinetics, Llc
Cranio/Sculpt C, 10cc, Bone Void Filler, UDI: 00813845021129 - Product Usage: CRANIO/SCULPT C is a calcium phosphate bone void filler ind...
Surgical Devices·125 affected·Apr 3, 2020
RecallFDA
Pega Medical Inc.
Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medullary (SLIM) System - Product Usage: The SLIM handle is the gri...
Surgical Devices·3 affected·Apr 3, 2020
High RiskFDA
C.a. Greiner & Sohne Gesellschaftmbh
VACUETTE Blood Transfer Unit. Lot no. A19024NX. Expiration date: 2022-02-07 - Product Usage: The Blood Transfer Unit is used to transfer ...
Medical Devices·90,400 affected·Apr 3, 2020
CriticalFDA
Heartware, Inc.
Heartware HVAD Pump Outflow Graft, Product (REF) Number 1125
Cardiac Devices·20,147 affected·Apr 3, 2020
CriticalFDA
Heartware, Inc.
Heartware HVAD Pump Implant Kit, Product (REF) Number 1104
Medical Implants·2,225 affected·Apr 3, 2020
CriticalFDA
Heartware, Inc.
Heartware HVAD Pump Implant Kit, Product (REF) Number 1104JP
Medical Implants·85 affected·Apr 3, 2020
RecallFDA
Immersivetouch Inc
ImmersiveView software version 2.1 Product Usage: ImmersiveView is intended as pre-operative software for simulating and evaluating s...
Surgical Devices·2 affected·Apr 3, 2020
RecallCPSC
Toy Stores Nationwide And Online At Www.manhattantoy.com, Amazon.com And Other Websites From October 2019 Through February 2020 For About $50.
Manhattan Toy Recalls Musical Lili Llama Due to Choking Hazard
Toys·4,000 affected·Apr 2, 2020
CriticalCPSC
Rooms To Go, Art Van, Nebraska Furniture Mart, And Other Furniture Stores Nationwide From January 2019 Through September 2019 For Between Approximately $1000 And $2500.
Southern Motion Recalls "Wireless Power" Reclining Furniture Due to Fire Hazard
Furniture·2,300 affected·Apr 2, 2020
CriticalCPSC
Electrical Distributors Nationwide From March 2018 Through December 2019 For Between $140 To $370.
Stelpro Design Recalls Sonoma Wall Fan Heaters Due to Fire Hazard
Heating & Cooling·3,600 affected·Apr 2, 2020
RecallCPSC
Bicycle Stores Nationwide And Online At Various Websites From Approximately May 2017 Through December 2017 For Between $113 And $116 Each.
VP Harrier and Giant Pinner Bicycle Pedals Recalled Due to Fall and Injury Hazards; Made by VP Components
Bicycles & Wheeled Sports·5,400 affected·Apr 2, 2020
High RiskFDA
Osteomed, Llc
OSTEOVATIONEX 3CC INJECT FORMULA. REF/UDI: 390-0003/00813845020016 - Product Usage: The product provides a bone void filler that is repla...
Medical Devices·270 affected·Apr 2, 2020
High RiskFDA
Osteomed, Llc
OSTEOVATION 5CC IMPACTFORMULA. REF/UDI: 390-2105/00813845020085 - Product Usage: The product provides a bone void filler that is replaced...
Medical Devices·1,724 affected·Apr 2, 2020
High RiskFDA
Osteomed, Llc
OSTEOVATION RMX Injectable BVF 5CC . REF/UDI: 390-6001/ /00813845021082 - Product Usage: The product provides a bone void filler that is ...
Medical Devices·278 affected·Apr 2, 2020
High RiskFDA
Osteomed, Llc
OSTEOVATIONEX 5CC INJECT FORMULA. REF/UDI: 390-0005/00813845020023 - Product Usage: The product provides a bone void filler that is repla...
Medical Devices·647 affected·Apr 2, 2020
High RiskFDA
Osteomed, Llc
OSTEOVATION 10CC INJECT FORMULA. REF/UDI: 390-2010/00813845020061 - Product Usage: The product provides a bone void filler that is replac...
Medical Devices·436 affected·Apr 2, 2020
High RiskFDA
Ge Healthcare, Llc
Giraffe Shuttle. Upgrade Kits with part number 2109672-001 and 2109673-001 GTIN: 00840682110808.
Medical Devices·204 affected·Apr 2, 2020
High RiskFDA
Osteomed, Llc
OSTEOVATION 5CC INJECT FORMULA. REF/UDI: 390-2005/00813845020054 - Product Usage: The product provides a bone void filler that is replace...
Medical Devices·417 affected·Apr 2, 2020
High RiskFDA
Osteomed, Llc
OSTEOVATION 10 CC IMPACT FORMULA. REF/UDI: 390-2110/ /00813845021092 - Product Usage: The product provides a bone void filler that is rep...
Medical Devices·995 affected·Apr 2, 2020
RecallFDA
Rong Shing Trading Ny Inc
XinXing Dried Plum, Net Wt. 5.3 oz.(150g)
Food·0 affected·Apr 1, 2020