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U.S. Department of Health and Human Services

Medical Device Recalls

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R3 TM CERAMIC ACETABULAR LINER, BIOLOX® FORTE, 36 MM O.D. 54 MM O.D., REF 71338954, STERILE R, Q... 2 04/22/2011 Smith & Nephew Inc
R3 TM CERAMIC ACETABULAR LINER, BIOLOX® FORTE, 36 MM O.D. 62 MM O.D., REF 71338962, STERILE R, Q... 2 04/22/2011 Smith & Nephew Inc
R3 TM CERAMIC ACETABULAR LINER, BIOLOX® FORTE, 36 MM O.D. 56 MM O.D., REF 71338956, STERILE R, Q... 2 04/22/2011 Smith & Nephew Inc
R3 (TM) 28 MM I.D., 66/70 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339166, STERIL... 2 10/18/2010 Smith & Nephew Inc
R3 (TM) 28 MM I.D., 64 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339164, STERILE E... 2 10/18/2010 Smith & Nephew Inc
R3 (TM) 28 MM I.D., 62 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339162, STERILE E... 2 10/18/2010 Smith & Nephew Inc
R3 (TM) 28 MM I.D., 60 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339160, STERILE E... 2 10/18/2010 Smith & Nephew Inc
R3 (TM) 22 MM I.D., 58 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339158, STERILE E... 2 10/18/2010 Smith & Nephew Inc
R3 (TM) 22 MM I.D., 56 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339156, STERILE E... 2 10/18/2010 Smith & Nephew Inc
R3 (TM) 22 MM I.D., 54 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339154, STERILE E... 2 10/18/2010 Smith & Nephew Inc
R3 (TM) 22 MM I.D., 52 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339152, STERILE E... 2 10/18/2010 Smith & Nephew Inc
Tandem Unipolar, 46 MM CO-CR, REF 126646, Sterile, Smith & Nephew, Memphis TX 38116 Designed for... 2 09/24/2009 Smith & Nephew Inc
Reflection, Microstable Acetabular Liner, REF 71740250, 32mm ID, 50-52 OD, 1 each, sterile EO. Comp... 2 04/21/2009 Smith & Nephew Inc
Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 50 mm cup Ref.: 74120150. Hip implant ... 2 10/25/2007 Smith & Nephew Inc
Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 46 mm cup Ref.: 74120146. Hip implant ... 2 10/25/2007 Smith & Nephew Inc
Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 48 mm cup Ref.: 74120148. Hip implant ... 2 10/25/2007 Smith & Nephew Inc
Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 62 mm cup Ref.: 74120162. Hip implant ... 2 10/25/2007 Smith & Nephew Inc
Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 60 mm cup Ref.: 74120160. Hip implant ... 2 10/25/2007 Smith & Nephew Inc
Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 58 mm cup Ref.: 74120158. Hip implant ... 2 10/25/2007 Smith & Nephew Inc
Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 58 mm cup Ref.: 74120258. Hip implant ... 2 10/25/2007 Smith & Nephew Inc
Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 50 mm cup Ref.: 74120250. Hip implant ... 2 10/25/2007 Smith & Nephew Inc
Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 66 mm cup Ref.: 74120166. Hip implant ... 2 10/25/2007 Smith & Nephew Inc
Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 64 mm cup Ref.: 74120164. Hip implant ... 2 10/25/2007 Smith & Nephew Inc
Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 62 mm cup Ref.: 74120262. Hip implant ... 2 10/25/2007 Smith & Nephew Inc
Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 56 mm cup Ref.: 74120156. Hip implant ... 2 10/25/2007 Smith & Nephew Inc
Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 54 mm cup Ref.: 74120154. Hip implant ... 2 10/25/2007 Smith & Nephew Inc
Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 52 mm cup Ref.: 74120152. Hip implant ... 2 10/25/2007 Smith & Nephew Inc
Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup 46 mm cup Ref.: 74120146. Hip implant c... 2 10/25/2007 Smith & Nephew Inc
Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 44 mm cup Ref.: 74120144. Hip implant ... 2 10/25/2007 Smith & Nephew Inc
Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor, 58 mm cup Ref.: 74120158 2 06/07/2007 Smith & Nephew Inc
Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor, 56 mm cup Ref.: 74120156 2 06/07/2007 Smith & Nephew Inc
Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor, 50 mm cup Ref.: 74120150 2 06/07/2007 Smith & Nephew Inc
Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor, 46 mm cup Ref.: 74120146 2 06/07/2007 Smith & Nephew Inc
Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor, 60 mm cup Ref.: 74120160 2 06/07/2007 Smith & Nephew Inc
BRAND: SKIN-PREP - Pouch Labeling and Box / Carton Labeling ***smith&nephew ***#420400***... 2 07/06/2011 Smith & Nephew Inc.
PERI-LOC TARGETER 4.5MM DISTAL FEMUR, HANDLE, LEFT, NON-STERILE - Product Usage: used for adult and ... 2 08/10/2020 Smith & Nephew, Inc.
Birmingham Hip Resurfacing Acetabular Cup with Impactor: (a) Size 56 mm, REF 74120156 (b) Size 64 ... 2 05/21/2018 Smith & Nephew, Inc.
Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING ACETABULAR CUP W/IMPACTOR, REF Numbers: 74120144 (44... 2 09/10/2015 Smith & Nephew, Inc.
R3(TM) 28 MM I.D., 62 MM O.D. CONSTRAINED LINER, REF 71339162, QTY: (1), STERILE EO. Product Usag... 2 06/09/2015 Smith & Nephew, Inc.
R3(TM) 28 MM I.D., 60 MM O.D. CONSTRAINED LINER, REF 71339160, QTY: (1), STERILE EO, Product Usa... 2 06/09/2015 Smith & Nephew, Inc.
R3(TM) 22 MM I.D., 58 MM O.D. CONSTRAINED LINER, REF 71339158, QTY: (1), STERILE EO. Product Usag... 2 06/09/2015 Smith & Nephew, Inc.
R3(TM) 22 MM I.D., 56 MM O.D. CONSTRAINED LINER, REF 71339156, QTY: (1), STERILE EO. Product Usag... 2 06/09/2015 Smith & Nephew, Inc.
R3(TM) 22 MM I.D., 52 MM O.D. CONSTRAINED LINER, REF 71339152, QTY: (1), STERILE EO. Product Usag... 2 06/09/2015 Smith & Nephew, Inc.
Portex Lumbar Puncture Tray. Anesthesia Conduction Kit. 4826PL-20 - Product Usage: Portex lumbar pun... 2 04/29/2020 Smiths Medical ASD Inc.
Drill Guide - Chameleon FacetFuse Fixation System, Model: 11-00028 Rev. A FacetFuse Drill Guides ... 2 08/02/2013 SpineFrontier, Inc.
Stelkast Cross-over Acetabular Shell and Liner Hip System, Part Numbers SC3458-52, SC3474-52, SC3459... 2 04/07/2013 Stelkast Co
STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System The SYSTEM 1 E Liquid Chemical Steri... 2 04/12/2011 Steris Corporation Hopkins Facility
Stryker Scope Warmer, disposable. Endoscopic accessory composed of polyvinyl Chloride (PVC) and Sod... 2 09/29/2010 Stryker Endoscopy
Crossfire Acetabular II Insert. Catalog No: 2041C-2642. 2 07/20/2004 Stryker Howmedica Osteonics
Stryker Orthopaedics Universal Acetabular Cup Positioner/Impactor, REF 2101-0200, Non-Sterile, Howme... 2 10/07/2016 Stryker Howmedica Osteonics Corp.
Stryker PCA 10 Degree Hooded Acetabular Insert ID 22mm, Part of the Howmedica PCA Total Hip Syste... 2 11/17/2015 Stryker Howmedica Osteonics Corp.
Stryker Howmedica Osteonics RESTORATION Acetabular Augment System; Howmedica Osteonics Corp., A sub... 2 05/19/2015 Stryker Howmedica Osteonics Corp.
Trident PSL HA Solid Back 50 mm Includes Dome Hole Plug Ref 540-11-50E Intended for cementless... 2 02/03/2015 Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics Cancellous Bone Screw Howmedica Osteonics Corp. Stryker France Both the ... 2 12/11/2013 Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics Torx 6.5mm Cancellous Bone Screw Ref 2030-6525-1 The 6.5mm Cancellous Bo... 2 11/19/2012 Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics Torx 6.5mm Cancellous Bone Screw Ref 2030-6535-1 The 6.5mm Cancellous Bo... 2 11/19/2012 Stryker Howmedica Osteonics Corp.
Special Orthopaedic Solution Peri-Acetabular Prosthesis V40 Femoral Extension Component Produc... 2 11/13/2012 Stryker Howmedica Osteonics Corp.
Cutting Edge Acetabular Spherical Reamer 44 M, Stryker Howmedica Osteonics Howmedica Osteonics Corp.... 2 05/17/2012 Stryker Howmedica Osteonics Corp.
Stryker Modular Dual Mobility (MDM) Liner and X3 Acetabular Insert; Howmedica Osteonics Corp., 325 C... 2 11/16/2011 Stryker Howmedica Osteonics Corp.
Stryker Restoration ADM System X3 Acetabular Insert Howmedica Osteonics Corp., 325 Corporate Drive, ... 2 11/16/2011 Stryker Howmedica Osteonics Corp.
Total Hip Joint Replacement Accolade TMZF Plus 127 Neck Angle V40 Hip Stem #3 Accolade TMZF Pl... 2 10/20/2011 Stryker Howmedica Osteonics Corp.
Omnifit M/S PSL Porous Coated Acetabular Shell 40MM; Stryker Orthopaedics, Uses in primary and r... 2 02/07/2011 Stryker Howmedica Osteonics Corp.
Omnifit M/S PSL Porous Coated Acetabular Shell 54MM; Stryker Orthopaedics, Uses in primary and r... 2 02/07/2011 Stryker Howmedica Osteonics Corp.
Omnifit M/S PSL Porous Coated Acetabular Shell 50MM; Stryker Orthopaedics, Uses in primary and r... 2 02/07/2011 Stryker Howmedica Osteonics Corp.
Omnifit M/S PSL Porous Coated Acetabular Shell 48MM; Stryker Orthopaedics, Uses in primary and r... 2 02/07/2011 Stryker Howmedica Osteonics Corp.
Omnifit M/S PSL Porous Coated Acetabular Shell 46MM; Stryker Orthopaedics, Uses in primary and r... 2 02/07/2011 Stryker Howmedica Osteonics Corp.
Omnifit M/S PSL Porous Coated Acetabular Shell 44MM; Stryker Orthopaedics, Uses in primary and r... 2 02/07/2011 Stryker Howmedica Osteonics Corp.
Omnifit M/S PSL Porous Coated Acetabular Shell 42MM; Stryker Orthopaedics, Uses in primary and r... 2 02/07/2011 Stryker Howmedica Osteonics Corp.
Howmedica Restoration ADM Trial Cup Holder; Non Sterile; Benoist Girard, Cedex, France; Distribut... 2 04/19/2010 Stryker Howmedica Osteonics Corp.
Trident Acetabular Hip System Polyethylene Inserts, Stryker Orthopaedics, multiple sizes, Mahwah, NJ... 2 03/02/2010 Stryker Howmedica Osteonics Corp.
CuttingEdge Total Hip Instrumentation Surgical Protocol; Acetabular and Femoral Surgical Technique ... 2 01/11/2010 Stryker Howmedica Osteonics Corp.
Holding Forceps for Trident Acetabular System; non Sterile; Catalog number 2105-0000; Howmedica Os... 3 12/16/2009 Stryker Howmedica Osteonics Corp.
Lateral Decubitus Alignment Guide, Non Sterile; manual surgical instrument. The MIS Hip Acetabular ... 2 08/27/2009 Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics PAL Pelvic Alignment Level, Ref: PAL 400; Howmedica Osteonics Corp, 325 Corpora... 2 08/26/2009 Stryker Howmedica Osteonics Corp.
V 40 Femoral Head, Sterile, 22 mm; Catalog number 6260-4-122, Catalog number 6260-5-226; Howmedica O... 2 08/18/2009 Stryker Howmedica Osteonics Corp.
Trident Hemispherical Acetabular Shell; 72mm, Arc Deposited, Hydroxylapatite Coated, Multi holed; St... 2 08/13/2009 Stryker Howmedica Osteonics Corp.
Trident Acetabular System Surgical Protocol. Instructions for use of hip prosthesis. Literature Num... 2 08/04/2009 Stryker Howmedica Osteonics Corp.
Restoration Modular Cone Bodies; titanium Alloy and Hydroxyapatite, Sterile. Catalog number 6276-1-... 2 05/21/2009 Stryker Howmedica Osteonics Corp.
Secur-Fit Max Hip Stem These devices are modular components of a total hip system. These femoral ... 2 01/26/2009 Stryker Howmedica Osteonics Corp.
Primary Secur-fit Plus Max Hip Stem These devices are modular components of a total hip system. T... 2 01/26/2009 Stryker Howmedica Osteonics Corp.
Secur-Fit ARC/HA Collar Stem These devices are modular components of a total hip system. These fe... 2 01/26/2009 Stryker Howmedica Osteonics Corp.
Omnifit Normalized Hip Stem These devices are modular components of a total hip system. These fem... 2 01/26/2009 Stryker Howmedica Osteonics Corp.
Omnifit HFX Hip Stem These devices are modular components of a total hip system. These femoral stem... 2 01/26/2009 Stryker Howmedica Osteonics Corp.
Accolade HFx These devices are modular components of a total hip system. These femoral stems are... 2 01/26/2009 Stryker Howmedica Osteonics Corp.
Omnifit FC Cemented Stem These devices are modular components of a total hip system. These femora... 2 01/26/2009 Stryker Howmedica Osteonics Corp.
Omnifit Eon These devices are modular components of a total hip system. These femoral stems are i... 2 01/26/2009 Stryker Howmedica Osteonics Corp.
Japanese Omnifit Eon 127 NK These devices are modular components of a total hip system. These fem... 2 01/26/2009 Stryker Howmedica Osteonics Corp.
Reunion HA Fracture Stem These devices are modular components of a total hip system. These femora... 2 01/26/2009 Stryker Howmedica Osteonics Corp.
Omnifit HA Hip Stem These devices are modular components of a total hip system. These femoral stems... 2 01/26/2009 Stryker Howmedica Osteonics Corp.
Accolade C CS These devices are modular components of a total hip system. These femoral stems are... 2 01/26/2009 Stryker Howmedica Osteonics Corp.
6.5 Cancellous Bone Screw 25 mm; Responsible Firm on Label: Manufacturer, Howmedica Osteonics Corp.,... 2 09/22/2008 Stryker Howmedica Osteonics Corp.
Trident Hemispherical Acetabular Shells HA Solid BK 42mm- 74mm; Arc Deposited; Hydroxylapatite C... 2 06/12/2008 Stryker Howmedica Osteonics Corp.
Trident PSL Acetabular Shells; Trident PSL HA Solid Back, 40 mm to 73 mm, hip prosthesis component... 2 06/12/2008 Stryker Howmedica Osteonics Corp.
Trident Hemispherical Solid BK Acetabular Shells; 42mm to 74mm, Hydroxylapatite Coated; Multihole... 2 06/12/2008 Stryker Howmedica Osteonics Corp.
Trident PSL HA Cluster Acetabular Shell; Arc Deposited HA Coated Cluster Screw Holes. Hip prosthes... 2 10/25/2007 Stryker Howmedica Osteonics Corp.
HA Solid Back Acetabular Shell; Arc Deposited HA Coated Included Dome hole Plug; Hip prosthesis com... 2 10/25/2007 Stryker Howmedica Osteonics Corp.
Trident PSL Acetabular Shell;Arc Deposited;Hydroxylapatite Coated;Cluster Screw Holes;Howmedica Oste... 2 09/26/2007 Stryker Howmedica Osteonics Corp.
Acetabular Pressurizer; single use and six units per box. The Acetabular Pressurizer 0206-522-000... 2 11/14/2013 Stryker Instruments Div. of Stryker Corporation
Stryker PCD Precision System 13G Needle with Spineplex, sterile, single use, disposable , 4 units pe... 2 01/25/2012 Stryker Instruments Div. of Stryker Corporation
RAPID SYPHILIS TEST KIT, per insert, contents of the kit are: 1 Rapid Syphilis test cassette, 1 alc... 2 02/15/2005 Ups Supply Chain Solutions

*   The maximium 500 devices meeting your search criteria returned. Please narrow your search.
 
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