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Product Description
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Recall Class
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FDA Recall Posting Date
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Recalling Firm
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Roche ACCU-Chek Aviva Meter Kit, Roche Diagnostics, Indianapolis, IN; REF 04893247001 includes the R...
|
2
|
08/11/2009
|
Roche Diagnostics Corp.
|
Roche ACCU-CHEK Compact Plus Meter Kit, Roche Diagnostics, Indianapolis, IN; REFS 03149137001, 05177...
|
2
|
08/11/2009
|
Roche Diagnostics Corp.
|
Roche Coaguchex XS Systems for Patient Self-Testing, Roche Diagnostics, Indianapolis, IN; REF 048377...
|
2
|
08/11/2009
|
Roche Diagnostics Corp.
|
Roche ACCU-Chek Voicemate Meter, Roche Diagnostics, Indianapolis, IN; REF 12030802001 includes the R...
|
2
|
08/11/2009
|
Roche Diagnostics Corp.
|
Roche ACCU-Chek Active Meter Kit, Roche Diagnostics, Indianapolis, IN; REF 03184501001 includes the ...
|
2
|
08/11/2009
|
Roche Diagnostics Corp.
|
Roche ACCU-CHEK Softclix Lancing Device, Distributed by Roche Diagnostics, Indianapolis, IN. Models...
|
2
|
08/11/2009
|
Roche Diagnostics Corp.
|
Roche Diagnostics NAPA2, N-Acetyl-Procainamide, COBAS INTEGRA, Roche Diagnostics, Indianapolis, IN.;...
|
2
|
10/09/2008
|
Roche Diagnostics Corp.
|
Roche Acetaminophen assay
03255379160-HAcetaminophen (P)
20767174160- cobas c Integra AAcetaminoph...
|
2
|
04/25/2018
|
Roche Diagnostics Corporation
|
Acetaminophen Test System for use on the COBAS/INTEGRA/cobas c, part number 20767174322, Roche Dia...
|
2
|
03/16/2011
|
Roche Diagnostics Operations, Inc.
|
Acetaminophen Test System for use on the Roche/Hitachi, part number 03255379190, Roche Diagnostics ...
|
2
|
03/16/2011
|
Roche Diagnostics Operations, Inc.
|
ONLINE TDM N-acetylprocainamide, Part number 04642520190 N- acetylprocainamide reagent Roche Diagno...
|
2
|
09/08/2010
|
Roche Diagnostics Operations, Inc.
|
Synvisc-One ® (hylan G-F 20), 6mL delivered from a 10mL syringe
Product Usage:
A elastoviscous h...
|
2
|
02/14/2018
|
Sanofi Genzyme
|
Safety Lancet for capillary blood sampling, 1.6 mm x 28G, Mini, Sarstedt. (Blood lancet)
|
2
|
10/14/2008
|
Sarstedt Inc
|
MULTIGENT Acetaminophen for use with Architect/Aeroset
Cat. No. 2K99-20.
Assay is intended for t...
|
2
|
06/27/2012
|
Sekisui Diagnostics Llc
|
Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay, In-vitro Diagnostic
Catalog Number: ...
|
2
|
03/14/2016
|
Sekisui Diagnostics P.E.I. Inc.
|
Siemens CLINITEK Atlas Positive and Negative Control Strips for Urine
Chemistry
Catalog Number: 50...
|
3
|
01/04/2013
|
Siemens Healthcare Diagnostics Inc
|
Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry
Catalog Number:1360
C...
|
3
|
01/04/2013
|
Siemens Healthcare Diagnostics Inc
|
Siemens Chek-Stix Combo Pak
Catalog Number: 1364
Chek-Stix® Positive and Negative Control Strip...
|
3
|
01/04/2013
|
Siemens Healthcare Diagnostics Inc
|
Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry
(Distributed OUS Only)
...
|
3
|
01/04/2013
|
Siemens Healthcare Diagnostics Inc
|
Siemens Chek-Stix Combo Pak (Distributed OUS only)
Catalog Number: 1364M
Chek-Stix® Positive and...
|
3
|
01/04/2013
|
Siemens Healthcare Diagnostics Inc
|
Siemens Chek-Stix Combo Pak
(Distributed OUS only)
Catalog Number: 1364N
Chek-Stix® Positive a...
|
2
|
01/04/2013
|
Siemens Healthcare Diagnostics Inc
|
Siemens Chek-Stix Combo Pak
(Distributed OUS)
Catalog Number: 1364E
Chek-Stix® Positive and Neg...
|
3
|
01/04/2013
|
Siemens Healthcare Diagnostics Inc
|
ADVIA Chemistry ToxAmmonia Calibrator- In vitro diagnostic use in the calibration of ethanol (ETOH_2...
|
2
|
05/25/2023
|
Siemens Healthcare Diagnostics, Inc.
|
Atellica CH Toxicology Calibrator (TOX CAL)-The Atellica® CH Toxicology Calibrator (TOX CAL) is for ...
|
2
|
05/25/2023
|
Siemens Healthcare Diagnostics, Inc.
|
Syva® EMIT® II Plus 6-Acetyl morphine
Catalog # for 28 mL: 9R039UL /SMN# 10470440
|
3
|
05/10/2018
|
Siemens Healthcare Diagnostics, Inc.
|
Syva® EMIT® II Plus 6-Acetylmorphine
Catalog # for 1000 mL: 9R129UL /SMN# 10481483
|
3
|
05/10/2018
|
Siemens Healthcare Diagnostics, Inc.
|
ADVIA Chemistry Acetaminophen reagents; for in vitro diagnostic use in the quantitative determinatio...
|
2
|
08/19/2015
|
Siemens Healthcare Diagnostics, Inc.
|
Microseal Augmented (20 degrees) Liner, acetabular liner component made from UHMW polyethylene (ASTM...
|
2
|
10/22/2014
|
Signal Medical Corporation
|
Signature Ceramic Femoral Head. Model Number: 111-152-621.
The Signature ceramic femoral heads are ...
|
2
|
03/06/2018
|
Signature Orthopedics Pty Limited
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REFLECTION(R), MICROSTABLE(R), ACETABULAR LINER, 20o OVERHANG, 28 MM ID, 54-56 OD, QTY: (1), STERILE...
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2
|
12/26/2013
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Smith & Nephew Inc
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R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 62 MM OD, QTY: (1), STERILE H2O2, REF ...
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2
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08/08/2013
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Smith & Nephew Inc
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R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 60 MM OD, QTY: (1), STERILE H2O2, REF ...
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2
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08/08/2013
|
Smith & Nephew Inc
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ACETABULAR PIN, REF 71366301, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116
Orth...
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2
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06/06/2012
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Smith & Nephew Inc
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R3 TM CERAMIC ACETABULAR LINER, BIOLOX® FORTE, 36 MM O.D. 56 MM O.D., REF 71338956, STERILE R, Q...
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2
|
04/22/2011
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Smith & Nephew Inc
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R3 TM CERAMIC ACETABULAR LINER, BIOLOX® FORTE, 36 MM O.D. 62 MM O.D., REF 71338962, STERILE R, Q...
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2
|
04/22/2011
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Smith & Nephew Inc
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R3 TM CERAMIC ACETABULAR LINER, BIOLOX® FORTE, 32 MM O.D. 55 MM O.D., REF 71338950, STERILE R, Q...
|
2
|
04/22/2011
|
Smith & Nephew Inc
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R3 TM CERAMIC ACETABULAR LINER, BIOLOX® FORTE, 36 MM O.D. 54 MM O.D., REF 71338954, STERILE R, Q...
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2
|
04/22/2011
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Smith & Nephew Inc
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R3 TM CERAMIC ACETABULAR LINER, BIOLOX® FORTE, 32 MM I.D. 48 MM O.D., REF 71338948, STERILE R, Q...
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2
|
04/22/2011
|
Smith & Nephew Inc
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R3 TM CERAMIC ACETABULAR LINER, BIOLOX® FORTE, 36 MM O.D. 52 MM O.D., REF 71338952, STERILE R, Q...
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2
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04/22/2011
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Smith & Nephew Inc
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R3 (TM) 28 MM I.D., 66/70 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339166, STERIL...
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2
|
10/18/2010
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Smith & Nephew Inc
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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...
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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., 52 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339152, 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., 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., 58 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339158, 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, 62 mm cup Ref.: 74120262. 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 ...
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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, 60 mm cup Ref.: 74120160. Hip implant ...
|
2
|
10/25/2007
|
Smith & Nephew Inc
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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, 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, 50 mm cup Ref.: 74120150. 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, 46 mm cup Ref.: 74120146. Hip implant ...
|
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 46 mm cup Ref.: 74120146. Hip implant c...
|
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 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) 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.
|
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., 58 MM O.D. CONSTRAINED LINER, REF 71339158, 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.
|
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 Restoration ADM System X3 Acetabular Insert Howmedica Osteonics Corp., 325 Corporate Drive, ...
|
2
|
11/16/2011
|
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.
|
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 44MM;
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 48MM;
Stryker Orthopaedics,
Uses in primary and r...
|
2
|
02/07/2011
|
Stryker Howmedica Osteonics Corp.
|