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High RiskFDA
Teva Pharmaceuticals Usa
Daunorubicin Hydrochloride Injection, 20 mg/4 mL (5 mg/mL), 4 mL Single Dose Vial, Rx ONLY, For IV Use Only, Manufactured By: Teva parent...
Injectable Drugs·13,520 affected·Oct 11, 2013
High RiskFDA
Hospira Inc.
0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 50 mL, Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045. ND...
Drugs·65,109 affected·Oct 11, 2013
High RiskFDA
Sandoz Inc
Fosinopril Sodium and Hydrochlorothiazide Tablets, 10 mg/12.5 mg, Rx Only, 100 Tablets, Sandoz Inc. Princeton, NJ 08540 ---NDC 0185-0341-01,
Oral Drugs·2,491 affected·Oct 11, 2013
High RiskFDA
Hospira Inc.
Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL single patient infusion vial packaged in 5 Units x 20 mL per carton, Rx ...
Injectable Drugs·70,450 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
2.7 X 6 CORT SCREW/SELFTA 2.7 X 7 CORT SCREW/SELFTA 2.7 X 8 CORT SCREW/SELFTA 2.7 X 9 CORT SCREW/SELFTA 2.7 X 10 CORT SCREW/SELFT 2....
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
1.5 X 6 CORT SCREW HEX/SE 2.0 X 6 CORT SCREW HEX/SE 2.0 X 10 CORT SCREW CRUCI 2.0 X 12 CORT SCREW CRUCI 2.0 X 14 CORT SCREW CRUCI 2....
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
PRESSFIT FEM ST FX 16 X 1
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
3.5 X 10 CORT SCREW SELFT 3.5 X 12 CORT SCREW SELFT 3.5 X 14 CORT SCREW SELFT 3.5 X 16 CORT SCREW SELFT 3.5 X 18 CORT SCREW SELFT 3....
Medical Devices·7,044,680 affected·Oct 11, 2013
CriticalFDA
Codman & Shurtleff, Inc.
TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System: One 1 g tube of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial o...
Surgical Devices·7,983 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
12/14 COCR FEMORAL HEAD (2, 3 and 4); 12/14 FEMORAL HEAD (+7X28M and 7X32M)
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
MOORE HIP PROS LONG FENES, MOORE HIP PROS NRW STR FE, MOORE HIP PROS STR FENEST, THOMPSON HIP PROSTHESIS 3, 4, 5 and 6.
Medical Implants·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
CPT 12/14 COCR (various sizes)
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
Bipolar liners and Multipolar cups with the following dimensions in MM (38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 53, 54, 55, 5...
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
Magna-Fx Cannulated Screw Fixation System 7.0 mm. Item codes starting with 0011420, 11460 and 11461.
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
VERSA-FX KEYLESS 90D X 8 and X 11, VERSA-FX KEYLESS 95D X 8, X 11, and X 14, VERSA-FX KEYLESS 140D X 4 and X 5, VERSA-FX KEYLESS 135D X 4...
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
RECON SCREW LG 5.5MM DIA and M/DN FEM IM NAIL 8MM DIA to 16 MM DIA. Item codes starting with 0022520, 0022521, 002522, 0022523, 0022524...
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
3.5 COMP PLT, 4 HOLE 3.5 COMP PLT, 5 HOLE 3.5 COMP PLT, 6 HOLE 3.5 COMP PLT, 8 HOLE 3.5 COMP PLT, 9 HOLE 3....
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
DISTAL MEDIAL FEMORAL CON, DISTAL POSTERIOR/LATERAL, DISTAL SMALL VOLAR RADIUS, PROXIMAL DORSAL ULNA PLT, and PROXIMAL MEDIAL TIBIAL 4.
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
ZIMTRON 6 DEG 22 HEADS
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
ASIA ONE-PIECE LAG SCREW
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
HERBERT BONE SCREW, 3.0MM and HERBERT CANNULATED BONE S
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
CPT DEGREE TAPER (various sizes) and FEMORAL HD (various sizes)
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
M/DN HUMERAL I/M NAIL. Sizes from 6 MM to 13 MM. Codes starting with 0022541, 002542 and 0022543.
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
INTERLOCKING IM SCREW SML, MED and LRG; M/DN TIBIAL I/M NAIL 6 MM to 15 MM. Some items starting with codes 0022530, 0022531, 002532, 0...
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
COMPRESSION SCREW (1/2, 1-1/2, 1-1/4, 1-3/4, 1. 2. 3/4 IN)
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
12/14 UNIPOLAR FEMORAL HE VERSYS CEM LD/FX SZ 11X12 VERSYS CEM LD/FX SZ 12X12 VERSYS CEM LD/FX SZ 14X13 VERSYS CEM LD/FX SZ 16X14 VE...
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Ge Healthcare, Llc
GE Vivid E9 ultrasound system. GE Vivid E9 is a Track 3 diagnostic ultrasound system, which is primarily intended for cardiac imaging an...
Cardiac Devices·710 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
TRILOGY ACET SHELL 36MM O TRILOGY ACET SHELL 38MM O TRILOGY ACET SHELL 40MM O TRILOGY ACET SHELL 42MM O TRILOGY ACET SHELL 44MM O TR...
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
MODULAR AUSTIN MOORE SOLI and MOORE HIP PROS REG SOLID
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Becton Dickinson & Co.
BD GeneOhm Cdiff Assay, Part #441401, containing Lysis Kit sample buffer tubes, 200 tests/kit; labeled as ***GeneOhm Sciences Canada, Inc...
Diagnostic Devices·33 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
NEXGEN MIS TIBIA PLATE PR NEXGEN TAPER PLUG NEXGEN PRECOAT PEG TIB PL NEXGEN MICRO ALL-POLY PAT NEXGEN ALL-POLY PATELLA, NE...
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
HGP II ACETABULAR CUP MOD
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
HGP II ACETABULAR CUP BON
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
6 DEGREE COCR FEM HEAD 36
Medical Devices·7,044,680 affected·Oct 11, 2013
CriticalFDA
Codman & Shurtleff, Inc.
TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System; Two 1 g tubes of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial ...
Surgical Devices·3,860 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
ONE-PIECE LAG SCREW 11MM. Item codes starting with 00225900.
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
VERSA-FX II KEYLESS TUBE, VERSA-FX II KEYLESS SHORT, VERSA-FX II SHORT TUBE PL, VERSA-FX II STD TUBE PLAT and VERSA-FX II SUPRACONDYLR ...
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
I/B II KNEE DOMED PATELLA, I/B II KNEE FLUTED ROD (1 and 2), MGII KNEE 10MM PATELLA (2,3 and 4), MGII KNEE SLF-TAP BONE ST
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance iCT Computed Tomography X-Ray System, Product Usage: The Brilliance iCT is a Computed Tomography X-Ray System intended ...
Medical Devices·9 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
M/DN R-F IM NAIL 9MM DIA , 10 MM, 11 MM, 12 MM, 13 MM and 14 MM. Item codes starting with 0022400
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Prothera, Inc.
Klaire Labs Interfase; Enzyme Supplement; Packaged in 60 and 120 Vegetarian capsules bottles. UPC 60 ct.- 7 0961 012270 7; UPc 120...
Supplements·243,851 affected·Oct 10, 2013
High RiskFDA
Prothera, Inc.
Klaire Labs Vital-Zymes Chewable; Comprehensive Enzyme Supplement; 180 Chewable tablets. UPC 7 09616 0218 5 Manufactured by ProTh...
Supplements·82,746 affected·Oct 10, 2013
High RiskFDA
Prothera, Inc.
Klaire Labs Interfase Plus; Enzyme Supplement; 120 Vegetarian capsules bottles. UPC 7 09616 01228 4 Manufactured by ProThera, I...
Supplements·0 affected·Oct 10, 2013
High RiskFDA
Prothera, Inc.
Serralase Enzyme Supplements; Packaged in 90 and 180 tablet bottled UPC - 90 count: 8 28054 00542 6 UPC- 180 count 8 28054 00149 7; ...
Supplements·27,480 affected·Oct 10, 2013
High RiskFDA
Nutrition Center, Inc. Dba Nutri-west
Total Enzyme, Dietary Supplement, Nutri-West, 120 capsules, Servicing Size 1 Capsule
Supplements·8,414 affected·Oct 10, 2013
High RiskFDA
Prothera, Inc.
Klaire Labs Vital-Zymes complete; Comprehensive Enzyme Supplement; 120 Vegetarian tablets. UPC 790616310005 Manufactured by ProTh...
Supplements·187,941 affected·Oct 10, 2013
CriticalFDA
Barrel O' Fun Snack Foods Co.
the Snack Artist BBQ Flavored Potato Chips, Net Wt. 10 oz. (283 g), UPC 21130-29106. Distributed by Safeway, Inc. Pleasanton, CA 94566
Snacks & Candy·3 affected·Oct 10, 2013
High RiskFDA
Nutrition Center, Inc. Dba Nutri-west
Total Probiotics, Dietary Supplement, Nutri-West, 50 Capsules, Servicing Size 1 Capsule
Supplements·13,864 affected·Oct 10, 2013