Medical device recalls reported in 2012

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Reported	Recall	Class	Product	Firm
2012-11-28	Z-0323-2013	Class II	bioMerieux Kit	Biomerieux Inc
2012-11-28	Z-0324-2013	Class II	bioMerieux Kit	Biomerieux Inc
2012-11-28	Z-0325-2013	Class II	bioMerieux Kit	Biomerieux Inc
2012-11-28	Z-0326-2013	Class II	bioMerieux Kit	Biomerieux Inc
2012-11-28	Z-0327-2013	Class II	bioMerieux Kit	Biomerieux Inc
2012-11-28	Z-0328-2013	Class II	bioMerieux Kit	Biomerieux Inc
2012-11-28	Z-0329-2013	Class II	bioMerieux Kit	Biomerieux Inc
2012-11-28	Z-0330-2013	Class II	Corometrics Qwik Connect Plus Spiral Electrode- Model #7000AA0 A…	Vital Signs Devices, a GE Healthcare Company
2012-11-28	Z-0331-2013	Class II	Superstat Modified Collagen Hemostatic Sponge	Superstat Corp
2012-11-28	Z-0332-2013	Class II	Superstat Modified Collagen Hemostatic Sponge	Superstat Corp
2012-11-28	Z-0333-2013	Class II	Superstat Modified Collagen Hemostatic Sponge	Superstat Corp
2012-11-28	Z-0334-2013	Class II	Superstat Modified Collagen Hemostatic Sponge	Superstat Corp
2012-11-28	Z-0335-2013	Class II	Superstat Modified Collagen Hemostatic Sponge	Superstat Corp
2012-11-28	Z-0336-2013	Class II	Superstat Modified Collagen Hemostatic Sponge	Superstat Corp
2012-11-28	Z-0337-2013	Class II	Superstat Modified Collagen Hemostatic Sponge	Superstat Corp
2012-11-28	Z-0338-2013	Class II	Superstat Modified Collagen Hemostatic Sponge	Superstat Corp
2012-11-28	Z-0339-2013	Class II	Superstat Modified Collagen Hemostatic Sponge	Superstat Corp
2012-11-28	Z-0340-2013	Class II	Superstat Modified Collagen Hemostatic Sponge	Superstat Corp
2012-11-28	Z-0341-2013	Class II	Superstat Modified Collagen Hemostatic Sponge	Superstat Corp
2012-11-28	Z-0342-2013	Class II	Superstat Modified Collagen Hemostatic Sponge	Superstat Corp
2012-11-28	Z-0343-2013	Class II	Superstat Modified Collagen Hemostatic Sponge	Superstat Corp
2012-11-28	Z-0344-2013	Class II	IO Fix IntraOsseous Fixation System	Extremity Medical LLC
2012-11-28	Z-0345-2013	Class II	UniCel Dxl 800 Access Immunoassay System	Beckman Coulter Inc.
2012-11-28	Z-0346-2013	Class II	UniCel Dxl 600 Access Immunoassay System	Beckman Coulter Inc.
2012-11-28	Z-0347-2013	Class II	UniCel DxC 880i	Beckman Coulter Inc.
2012-11-28	Z-0348-2013	Class II	Screw Tulip	NuVasive Inc
2012-11-28	Z-0349-2013	Class II	5	NuVasive Inc
2012-11-28	Z-0350-2013	Class II	5	NuVasive Inc
2012-11-28	Z-0351-2013	Class II	5	NuVasive Inc
2012-11-28	Z-0352-2013	Class II	5	NuVasive Inc
2012-11-28	Z-0353-2013	Class II	5	NuVasive Inc
2012-11-28	Z-0354-2013	Class II	5	NuVasive Inc
2012-11-28	Z-0355-2013	Class II	6	NuVasive Inc
2012-11-28	Z-0356-2013	Class II	6	NuVasive Inc
2012-11-28	Z-0357-2013	Class II	6	NuVasive Inc
2012-11-28	Z-0358-2013	Class II	6	NuVasive Inc
2012-11-28	Z-0359-2013	Class II	6	NuVasive Inc
2012-11-28	Z-0360-2013	Class II	6	NuVasive Inc
2012-11-28	Z-0361-2013	Class II	7	NuVasive Inc
2012-11-28	Z-0362-2013	Class II	7	NuVasive Inc
2012-11-28	Z-0363-2013	Class II	7	NuVasive Inc
2012-11-28	Z-0364-2013	Class II	7	NuVasive Inc
2012-11-28	Z-0365-2013	Class II	7	NuVasive Inc
2012-11-28	Z-0366-2013	Class II	7	NuVasive Inc
2012-11-28	Z-0367-2013	Class II	Screw Tulip	NuVasive Inc
2012-11-28	Z-0368-2013	Class II	4	NuVasive Inc
2012-11-28	Z-0369-2013	Class II	4	NuVasive Inc
2012-11-28	Z-0370-2013	Class II	5	NuVasive Inc
2012-11-28	Z-0371-2013	Class II	5	NuVasive Inc
2012-11-28	Z-0372-2013	Class II	5	NuVasive Inc
2012-11-28	Z-0373-2013	Class II	6	NuVasive Inc
2012-11-28	Z-0374-2013	Class II	6	NuVasive Inc
2012-11-28	Z-0375-2013	Class II	6	NuVasive Inc
2012-11-28	Z-0376-2013	Class II	7	NuVasive Inc
2012-11-28	Z-0377-2013	Class II	7	NuVasive Inc
2012-11-28	Z-0378-2013	Class II	7	NuVasive Inc
2012-11-28	Z-0379-2013	Class III	Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO	Microgenics Corporation
2012-11-28	Z-0380-2013	Class II	Stryker XIA 3 TORQUE WRENCH REF 48237028 Manufactured by: Stryker…	Stryker Spine
2012-11-28	Z-0381-2013	Class II	Stryker MANTIS TORQUE WRENCH REF 48287028 Manufactured by: Stryker…	Stryker Spine
2012-11-28	Z-0382-2013	Class II	SPECIALTY AUDIBLE TORQUE WRENCH	Stryker Spine
2012-11-28	Z-0383-2013	Class II	"*SENTINELCannulated Drill BitS8580*8 X 229mm	Linvatec Corp. dba ConMed Linvatec
2012-11-28	Z-0384-2013	Class II	"*SENTINELCannulated Drill BitS8585*8	Linvatec Corp. dba ConMed Linvatec
2012-11-28	Z-0385-2013	Class II	The RIO	Mako Surgical Corporation
2012-11-28	Z-0386-2013	Class II	Trilogy II Constrained Liner The Trilogy Longevity Constrained Liner…	Zimmer, Inc.
2012-11-28	Z-0387-2013	Class II	Stryker Orthopaedics Torx 6	Stryker Howmedica Osteonics Corp.
2012-11-28	Z-0388-2013	Class II	Stryker Orthopaedics Torx 6	Stryker Howmedica Osteonics Corp.
2012-11-28	Z-0389-2013	Class II	Product 100789502202 VerSys Femoral Head Provisional 22mm +0…	Zimmer, Inc.
2012-11-28	Z-0390-2013	Class II	00789502601 VerSys Femoral Head Provisional 26mm -3	Zimmer, Inc.
2012-11-28	Z-0391-2013	Class II	. 00789502801 VerSys Femoral Head Provisional 28mm -3.5 00789502802…	Zimmer, Inc.
2012-11-28	Z-0392-2013	Class II	00789503201 VerSys Femoral Head Provisional 32mm -3	Zimmer, Inc.
2012-11-28	Z-0393-2013	Class II	. 00789503601 VerSys Femoral Head Provisional 36mm -3.5 00789503602…	Zimmer, Inc.
2012-11-28	Z-0394-2013	Class II	00789504001 VerSys Femoral Head Provisional 40mm -3	Zimmer, Inc.
2012-11-28	Z-0395-2013	Class II	00780302201 MIS 12/14 Slotted Femoral Head Provisional -2X22…	Zimmer, Inc.
2012-11-28	Z-0396-2013	Class II	00780302601 MIS 12/14 Slotted Femoral Head Provisional -3	Zimmer, Inc.
2012-11-28	Z-0397-2013	Class II	00780302801 MIS 12/14 Slotted Femoral Head Provisional -3	Zimmer, Inc.
2012-11-28	Z-0398-2013	Class II	00780303201 MIS 12/14 Slotted Femoral Head Provisional -3	Zimmer, Inc.
2012-11-28	Z-0399-2013	Class II	00780303601 MIS 12/14 Slotted Femoral Head Provisional -3	Zimmer, Inc.
2012-11-28	Z-0400-2013	Class II	00780304001 MIS 12/14 Slotted Femoral Head Provisional -3	Zimmer, Inc.
2012-11-28	Z-0401-2013	Class II	BioPlant	Kerr Corporation
2012-11-28	Z-0402-2013	Class II	Freedom Cordless LED Light System	Kerr Corporation
2012-11-28	Z-0403-2013	Class II	qube Compact Monitor	Spacelabs Healthcare, Llc
2012-11-28	Z-0404-2013	Class II	INTRABEAM Balloon Applicator Set	Carl Zeiss Meditec, Inc.
2012-11-28	Z-0405-2013	Class II	INTRABEAM Balloon Applicator Set	Carl Zeiss Meditec, Inc.
2012-11-28	Z-0406-2013	Class II	INTRABEAM Balloon Applicator Set	Carl Zeiss Meditec, Inc.
2012-11-28	Z-0407-2013	Class II	Vital Signs Disposable General Purpose 9 French Temperature Probe For…	Vital Signs Colorado Inc.
2012-11-28	Z-0408-2013	Class II	Dimension Vista	Siemens Healthcare Diagnostics, Inc.
2012-11-28	Z-0409-2013	Class II	RotoRest Delta Kinetic Therapy System INDICATIONS: Treatment and…	KCI USA, Inc.
2012-11-28	Z-0410-2013	Class II	Multipolar¿ Bipolar Cup Liner 22 mm LD	Zimmer, Inc.
2012-11-28	Z-0411-2013	Class II	PARPARELLA-TYPE VENT TUBE	Gyrus Acmi, Incorporated
2012-11-28	Z-0412-2013	Class II	Spine Frontier Inspan compressors Part Number: 11-60004	SpineFrontier, Inc.
2012-11-28	Z-0413-2013	Class II	CapLOX II Final Torque Driver	Captiva Spine, Inc
2012-11-28	Z-0414-2013	Class II	The brand name of the device is Laser Loupes	Kerr Corporation
2012-11-28	Z-0415-2013	Class II	Ranawat/Burnstein Acetabular Shell 54mm/Limited Holes/Porous Coated…	Biomet, Inc.
2012-11-28	Z-0416-2013	Class II	The Trilogy Acetabular System Shell with Cluster Holes Porous 56 mm O	Zimmer, Inc.
2012-11-28	Z-0417-2013	Class II	S-Lift Implant Guides	SpineFrontier, Inc.
2012-11-28	Z-0418-2013	Class II	KING LAD SILI CONE SINGLE USE	King Systems Corp.
2012-11-28	Z-0419-2013	Class II	KING LAD SILI CONE SINGLE USE	King Systems Corp.
2012-11-28	Z-0420-2013	Class II	KING LAD SILI CONE SINGLE USE	King Systems Corp.
2012-11-28	Z-0421-2013	Class II	KING LAD SILI CONE SINGLE USE	King Systems Corp.
2012-11-28	Z-0422-2013	Class II	KING LAD Standard ClearSeal SINGLE USE	King Systems Corp.
2012-11-28	Z-0423-2013	Class II	KING LAD Standard ClearSeal SINGLE USE	King Systems Corp.
2012-11-28	Z-0424-2013	Class II	KING LAD Standard ClearSeal SINGLE USE	King Systems Corp.
2012-11-28	Z-0425-2013	Class II	KING LAD Standard ClearSeal SINGLE USE	King Systems Corp.
2012-11-28	Z-0426-2013	Class II	KING LAD Flexible ClearSeal SINGLE USE	King Systems Corp.
2012-11-28	Z-0427-2013	Class II	KING LAD Flexible ClearSeal SINGLE USE	King Systems Corp.
2012-11-28	Z-0428-2013	Class II	IMRIS ORT100	Innovative Magnetic Resonance Imaging Systems Inc.
2012-11-28	Z-0429-2013	Class III	Minotrol 16	Horiba Instruments, Inc dba Horiba Medical
2012-11-28	Z-0430-2013	Class II	0	Biomerieux Inc
2012-11-28	Z-0431-2013	Class II	Styker Orthobiologics Vita Plasma Separator	Stryker Orthobiologics, Inc.
2012-11-28	Z-0432-2013	Class II	4	OrthoPediatrics Corp
2012-11-28	Z-0433-2013	Class II	SenTec V-Sign Membrane Changer	Sentec AG
2012-11-28	Z-0434-2013	Class II	SenTec V-Sign Membrane Changer Insert	Sentec AG
2012-11-21	Z-0276-2013	Class II	Progressive Medical PMI Endoscopic Dissector with Kittner Tip	Progressive Medical Inc
2012-11-21	Z-0277-2013	Class II	Synthes External Fixation System Tube to Tube Clamp	Synthes USA HQ, Inc.
2012-11-21	Z-0278-2013	Class II	HX2 Temp Manage SYS 120V The Terumo HX2 Temperature Management System…	Terumo Cardiovascular Systems Corporation
2012-11-21	Z-0279-2013	Class II	Tested AC Control BD	Terumo Cardiovascular Systems Corporation
2012-11-21	Z-0280-2013	Class II	Perfusion System 8000	Terumo Cardiovascular Systems Corporation
2012-11-21	Z-0281-2013	Class II	Perfusion System 8000	Terumo Cardiovascular Systems Corporation
2012-11-21	Z-0282-2013	Class II	Perfusion System 8000	Terumo Cardiovascular Systems Corporation
2012-11-21	Z-0283-2013	Class II	Perfusion System 8000	Terumo Cardiovascular Systems Corporation
2012-11-21	Z-0284-2013	Class II	Perfusion System 8000	Terumo Cardiovascular Systems Corporation
2012-11-21	Z-0285-2013	Class II	Perfusion System 8000	Terumo Cardiovascular Systems Corporation
2012-11-21	Z-0286-2013	Class II	Special Orthopaedic Solution Peri-Acetabular Prosthesis V40 Femoral…	Stryker Howmedica Osteonics Corp.
2012-11-21	Z-0287-2013	Class II	PT Link Waterbath	Dako North America Inc.
2012-11-21	Z-0288-2013	Class II	TriVascular brand Fill Polymer Kit	Trivascular, Inc
2012-11-21	Z-0289-2013	Class III	ABX PENTRA Creatinine 120 CP	Horiba Instruments, Inc dba Horiba Medical
2012-11-21	Z-0294-2013	Class II	EnteraLite Infinity Enteral Feeding Pump identified with the…	MOOG Medical Devices Group
2012-11-21	Z-0295-2013	Class II	Select Medical Products Vinyl Powder-Free Exam Gloves	Gulf South Medical Supply Inc
2012-11-21	Z-0296-2013	Class II	ATS 3000 Automatic Tourniquet System w/HOSES AND LOP SENSOR Intended…	Zimmer, Inc.
2012-11-14	Z-0189-2013	Class III	Boule Con-Diff Hematology Control For in vitro diagnostic use as a…	Clinical Diagnostic Solutions
2012-11-14	Z-0190-2013	Class III	Boule Con-Diff Hematology Control For in vitro diagnostic use as a…	Clinical Diagnostic Solutions
2012-11-14	Z-0191-2013	Class III	Boule Con-Diff Hematology Control For in vitro diagnostic use as a…	Clinical Diagnostic Solutions
2012-11-14	Z-0192-2013	Class III	Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 1	Abbott Point Of Care Inc.
2012-11-14	Z-0193-2013	Class III	Boule Con Diff US Tri Pack	Clinical Diagnostic Solutions
2012-11-14	Z-0194-2013	Class III	Boule Con-Diff Hematology Control 9 vials	Clinical Diagnostic Solutions
2012-11-14	Z-0195-2013	Class II	ABL80 FLEX CO-OX analyzer	Sendx Medical Inc
2012-11-14	Z-0196-2013	Class II	The touchscreen display	Spacelabs Healthcare, Llc
2012-11-14	Z-0201-2013	Class II	"***Sharpoint IQ Geometry Slit Knife Angled	Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.
2012-11-14	Z-0202-2013	Class II	"***Sharpoint IQ Geometry Slit Knife Angled	Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.
2012-11-14	Z-0203-2013	Class II	"***Sharpoint IQ Geometry Slit Knife Angled	Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.
2012-11-14	Z-0204-2013	Class II	"***Sharpoint IQ Geometry Slit Knife Angled	Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.
2012-11-14	Z-0205-2013	Class II	Vector TAS Modular Driver	Ormco/Sybronendo
2012-11-14	Z-0206-2013	Class II	Pinnacle3 VCC P/N 4598 001 41341 REV A	Philips Medical Systems (Cleveland), Inc.
2012-11-14	Z-0207-2013	Class II	Trochar Scalpel Instrument	OrthoPediatrics Corp
2012-11-14	Z-0208-2013	Class II	Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module…	Sechrist Industries Inc
2012-11-14	Z-0209-2013	Class II	Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module…	Sechrist Industries Inc
2012-11-14	Z-0210-2013	Class II	Alloclassic SL Shaft	Zimmer, Inc.
2012-11-14	Z-0211-2013	Class II	Biolox¿ delta Ceramic Femoral Head Rx only	Zimmer, Inc.
2012-11-14	Z-0212-2013	Class II	Biolox¿ Option Ceramic Femoral Head System Rx	Zimmer, Inc.
2012-11-14	Z-0213-2013	Class II	Wagner SL Revision Stem	Zimmer, Inc.
2012-11-14	Z-0214-2013	Class II	Alloclassic¿ SL-Offset Stem sterile	Zimmer, Inc.
2012-11-14	Z-0215-2013	Class II	Metasul¿ LDH¿ Head Rx Sterile	Zimmer, Inc.
2012-11-14	Z-0216-2013	Class II	Metasul¿ Durom¿ Femoral component Sterile	Zimmer, Inc.
2012-11-14	Z-0217-2013	Class II	MS-30¿ Stem	Zimmer, Inc.
2012-11-14	Z-0218-2013	Class II	MS-30¿ Distal centralizer	Zimmer, Inc.
2012-11-14	Z-0219-2013	Class II	MS-30¿ Proximal positioner	Zimmer, Inc.
2012-11-14	Z-0220-2013	Class II	Fitmore" Hip Stem	Zimmer, Inc.
2012-11-14	Z-0221-2013	Class II	Wagner cone Prosthesis	Zimmer, Inc.
2012-11-14	Z-0222-2013	Class II	CoCr Head	Zimmer, Inc.
2012-11-14	Z-0223-2013	Class II	Anatomical Shoulder" Humeral stem	Zimmer, Inc.
2012-11-14	Z-0224-2013	Class II	Anatomical Shoulder" Fracture Humeral stem	Zimmer, Inc.
2012-11-14	Z-0225-2013	Class II	Anatomical Shoulder" Humeral Head	Zimmer, Inc.
2012-11-14	Z-0226-2013	Class II	zimmer Anatomical Shoulder Glenoid S	Zimmer, Inc.
2012-11-14	Z-0227-2013	Class II	Anatomical Shoulder" Revision Humeral stem	Zimmer, Inc.
2012-11-14	Z-0228-2013	Class II	Zimmer Inverse/Reverse Screw system	Zimmer, Inc.
2012-11-14	Z-0229-2013	Class II	Anatomical Shoulder" Inverse Humeral Cup	Zimmer, Inc.
2012-11-14	Z-0230-2013	Class II	Anatomical Shoulder" Inverse/Reverse Glenoid Sterile	Zimmer, Inc.
2012-11-14	Z-0231-2013	Class II	Anatomical Shoulder" Inverse/Reverse Humeral PE-Insert Sterile	Zimmer, Inc.
2012-11-14	Z-0232-2013	Class II	Anatomical Shoulder" Ball taper for humeral stem	Zimmer, Inc.
2012-11-14	Z-0233-2013	Class II	Anatomical Shoulder" Fracture Humeral Head	Zimmer, Inc.
2012-11-14	Z-0234-2013	Class II	CLS Stem	Zimmer, Inc.
2012-11-14	Z-0235-2013	Class II	Original M	Zimmer, Inc.
2012-11-14	Z-0236-2013	Class II	Dynesys¿ Set screw M6	Zimmer, Inc.
2012-11-14	Z-0237-2013	Class II	Dynesys¿ Universal spacer 6-45	Zimmer, Inc.
2012-11-14	Z-0238-2013	Class II	Dynesys¿ L	Zimmer, Inc.
2012-11-14	Z-0239-2013	Class II	Dynesys¿ Revision + set screw	Zimmer, Inc.
2012-11-14	Z-0240-2013	Class II	Dynesys¿ HA Pedicle + set screw	Zimmer, Inc.
2012-11-14	Z-0241-2013	Class II	DTO" Implant	Zimmer, Inc.
2012-11-14	Z-0242-2013	Class II	Dynesys¿ Top-Loading System Cannulated Pedicle + Set Screw	Zimmer, Inc.
2012-11-14	Z-0243-2013	Class II	NCB¿ cancellous screw	Zimmer, Inc.
2012-11-14	Z-0244-2013	Class II	NCB¿ screw ¿ 4	Zimmer, Inc.
2012-11-14	Z-0245-2013	Class II	NCB¿-PT lateral proximal 3 hole tibial plate	Zimmer, Inc.
2012-11-14	Z-0246-2013	Class II	NCB¿-PH Plate	Zimmer, Inc.
2012-11-14	Z-0247-2013	Class II	Sirus¿ intramedullary nail for tibia	Zimmer, Inc.
2012-11-14	Z-0248-2013	Class II	Kopf Adapter S Sterile	Zimmer, Inc.
2012-11-14	Z-0249-2013	Class II	MS-30 Shaft	Zimmer, Inc.
2012-11-14	Z-0250-2013	Class II	Sunquest Laboratory	Sunquest Information Systems, Inc.
2012-11-14	Z-0251-2013	Class II	Sunquest Application Interfacing Outbound Phlebotomy Point of Care…	Sunquest Information Systems, Inc.
2012-11-14	Z-0252-2013	Class II	STA Satellite Automated Multi-Parameter Analyzer This system is a…	Diagnostica Stago, Inc.
2012-11-14	Z-0253-2013	Class III	Siemens Dimension Vista	Siemens Healthcare Diagnostics, Inc.
2012-11-14	Z-0254-2013	Class II	Sysmex XE-2100 Automated Hematology System	Sysmex America, Inc.
2012-11-14	Z-0255-2013	Class II	Sysmex XE-5000 Automated Hematology System	Sysmex America, Inc.
2012-11-14	Z-0256-2013	Class II	Sysmex XE-2100C Automated Hematology System	Sysmex America, Inc.
2012-11-14	Z-0257-2013	Class II	ULTRA Fabric Reinforced surgical Gown X-Large Sterile The product is…	Kimberly-Clark Corporation
2012-11-14	Z-0258-2013	Class II	MicroCool Breathable Gown with Towels	Kimberly-Clark Corporation
2012-11-14	Z-0259-2013	Class II	AMS AdVance" Male Sling System 720088-01 AMS AdVance" Male Sling…	American Medical Systems, Inc.
2012-11-14	Z-0260-2013	Class II	R-30H	Shimadzu Medical Systems
2012-11-14	Z-0261-2013	Class II	R-20J	Shimadzu Medical Systems
2012-11-14	Z-0262-2013	Class II	0	Shimadzu Medical Systems
2012-11-14	Z-0263-2013	Class II	0	Shimadzu Medical Systems

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