FDA Device Recalls

Recalls / Firms / Smith & Nephew, Inc. Endoscopy Division

Smith & Nephew, Inc. Endoscopy Division

128 FDA device recalls on record.

DateClassProductReason
2014-06-02SUTUREFIX Ultra S with 1 #2 Ultrabraid (blue) Product Code: 72203852 Fastener, fixation, nondegrada
2014-06-02SUTUREFIX Ultra S with 1 #2 Ultrabraid Suture (blue/white) Product Code: 72203853 Fastener, fixatio
2014-06-02SUTUREFIX Ultra S Double Loaded Suture Product Code: 72203854 Fastener, fixation, nondegradable, so
2014-06-02SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Cobraid Suture Product Code: 72203842 Fastener,
2014-06-02SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Blue Product Code: 72203841 Fastener, fixation,
2013-08-06TWINFIX Ultra 5.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID) with
2013-08-06TWINFIX Ultra HA 6.5 mm with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202631 Biodegradabl
2013-08-06TWINFIX Ultra PLLA/HA 6.5 mm with 3 ULTRABRAID Suture; Part Number: 72202610 Biodegradable suture a
2013-08-06BIORAPTOR 2.9 mm Suture Anchor Straight, pack of 2 ULTRABRAID Suture; Part Number: 72200690 Biodegr
2013-08-06OSTEORAPTOR 2.3 mm Suture Anchor with ULTRABRAID COBRAID Suture, Blue; Part Number: 72201993 Biod
2013-08-06TWINFIX Ultra HA 4.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202624
2013-08-06TWINFIX Ultra 6.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID) with
2013-08-06OSTEORAPTOR 2.3 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Black; Part Number: 72201992 Bi
2013-08-06TWINFIX Ultra HA 4.5 mm Suture Anchor with 2 ULTRABRAID Suture, White / Blue; Part Number: 72202597
2013-08-06RAPTORMITE" 3.7 mm PLLA with two ULTRABRAID" Sutures Size 0 and Needles; Part Number: 72201805 Biod
2013-08-06BIORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture; Part Number: 72200775 Biodegradable suture
2013-08-06BIORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture; Part Number: 72200774 Biodegradable suture
2013-08-06OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Blue ; Part Number: 72201995 Bi
2013-08-06TWINFIX ULTRA PLLA/HA 5.5 mm Suture Anchor with 3 ULTRABRAID Suture: Part Number: 72202603 Biodegra
2013-08-06TWINFIX" Ultra PLLA/HA 6.5 mm with 2 ULTRABRAID" Suture, White / Black: Part Number: 72202608 Biode
2013-08-06BIORAPTOR 2.9 mm Suture Anchor with DURABRAID" Suture; Part Number: 72200783 Biodegradable suture a
2013-08-06OSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture, White; Part Number: 72202165 Biodegrad
2013-08-06OSTEORAPTOR 2.3 mm with 1 ULTRABRAID Suture, White; Part Number: 72201991 Biodegradable suture anc
2013-08-06OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black; Part Number: 72201996 Bi
2013-08-06OSTOSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Blue; Part Number: 72201994
2013-08-06TWINFIX Ultra HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202626
2013-08-06OSTEORAPTOR CURVED 2.3 mm Suture Anchor ULTRABRAID COBRAID Suture, Black; Part Number: 72203291 Bi
2013-08-06TWINFIX Ultra PLLA/HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black: Part Number: 722
2013-08-06TWINFIX" Ultra 4.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID") wit
2013-08-06BIORAPTOR 2.9 mm Suture Anchor, pack of 1 ULTRABRAID Suture: 72200689 Biodegradable suture anchor
2013-08-06OSTEORAPTOR CURVED 2.3 mm Suture Anchor SA ULTRABRAID COBRAID Suture, Blue; Part Number: 72203290
2012-07-14Smith & Nephew 5.5 mm Dyonics Bonecutter ,Electroblade Full Radius Part Number: 7205962 Product Us
2012-07-14Smith & Nephew Dyonics Electroblade Resector, 4.5mm Full Radius Blade, BONECUTTER Part Number: 72202
2012-07-03Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures (COBRAID-blue, COBRAIDblack), ster
2012-07-03Smith & Nephew 5.5 mm TWINFIX Ultra Ti Suture Anchor with two #2 ULTRABRAID sutures (blue, blue-COBR
2012-07-03Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures(white, COBRAID-blue), sterile Part
2012-07-03Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with three #2 sutures (white, COBRAID- blue), sterile
2012-03-29Smith & Nephew 560P High Definition Camera Control Unit Catalog Number: 72201919 The 560P camera sys
2012-02-06Smith & Nephew BIOSURE HA Interference Screw, 7 mm x 25 mm Catalog Number: 72201772. The BIOSURE HA
2011-11-07Smith & Nephew 5.5mm DYONICS BONECUTTER ELECTROBLADE Resector Catalog Number: 7205962.
2011-09-23Smith & Nephew, HD1200 Autoclavable Camera Head Catalog Number: 72203360 Product Usage: Endoscope &
2011-07-26Smith & Nephew, SPIDER2 Limb Positioner, including accessories Battery, foot pedal and charger Catal
2011-07-07Smith & Nephew, Tendon Stripper, Slotted, 5.0 mm I.D. x 12 working length. Non-Sterile Catalog Numbe
2011-05-19Smith & Nephew Hip Arthroscopy Repair Instrument Tray Part Number: 72202732 Device Description-The
2011-05-06DYONICS POWER Shaver Blades, 4.5mm Long Full Radius, package of 3 Catalog Number: 7205341 Product U
2011-05-06DYONICS POWER Shaver Blades, 4.5mm Long Curved Full Radius Convex, package of 3. Catalog Number: 720
2010-10-14Smith & Nephew FAST FIX 360, CURVED NEEDLE Catalog Number; 72202468. Intended for use as a suture
2010-10-14Smith & Nephew FAST FIX 360, STRAIGHT NEEDLE Catalog Number; 72202467. Intended for use as a sutur
2010-10-14Smith & Nephew FAST FIX 360, REVERSE CURVED NEEDLE Catalog Number; 72202469. Intended for use as a
2010-04-29Smith & Nephew Aimer Endofemoral 5mm Offset (Red) Catalog Number: 72201715 ACUFEX Surgical Instrumen
2010-04-29Smith & Nephew Aimer Endofemoral 4mm Offset (Green) Catalog Number: 72201716F (Refurbished) ACUFEX S
2010-04-29Smith & Nephew Aimer Endofemoral 7mm Offset (Gold) Catalog Number: 72201717 ACUFEX Surgical Instrume
2010-04-29Smith & Nephew Aimer Endofemoral 4mm Offset (Purple) Catalog Number: 72201714F (Refurbished) ACUFEX
2010-04-29Smith & Nephew Aimer Endofemoral 3mm Offset (Blue) Catalog Number: 72201713 ACUFEX Surgical Instrume
2010-04-29Smith & Nephew Aimer Endofemoral 3mm Offset (Blue) Catalog Number: 72201713F (Refurbished) ACUFEX Su
2010-04-29Smith & Nephew Aimer Endofemoral 4mm Offset (Purple Catalog Number: 72201714 ACUFEX Surgical Instrum
2010-04-29Smith & Nephew Aimer Endofemoral 6mm Offset (Green) Catalog Number: 72201716 ACUFEX Surgical Instrum
2010-04-29Smith & Nephew Aimer Endofemoral 4mm Offset (Red) Catalog Number: 72201715F (Refurbished) ACUFEX Sur
2009-05-27DYONICS 25 Fluid Management System Disposable Inflow/Outflow Tubeset With Forked Suction Catalog Nu
2009-05-27DYONICS 25 Fluid Management System Disposable Inflow/Outflow Tubeset With Single Suction Catalog Nu
2009-05-07Smith & Nephew Endoscopic Disposable Blades: FULL RADIUS BLADE, 5.5MM,SER 3000 Part #: 7206010. DYO
2009-05-07Smith & Nephew Endoscopic Disposable Blades: STONECUTTER ACR,4.0,EP-1,DSP Part #: 7205330. DYONICS
2009-05-07Smith & Nephew Endoscopic Disposable Blades: BOXED F/R,BL,4.5MM,SERIES 3000 /6 Product #: 7206011.
2009-05-07Smith & Nephew Endoscopic Disposable Blades: DISPOSABLE BL,4.5MM FR ELITE Part #: 7210499. DYONICS
2009-05-07Smith & Nephew Endoscopic Disposable Blades:TURBOWHISKER BLD,EP-1,4.5MM(6) Part #: 7205316. DYONIC
2009-05-07Smith & Nephew Endoscopic Disposable Blades: INCISOR BLADE,3.5MM DSPL,EP-1 Part #: 7205312. DYONICS
2009-05-07Smith & Nephew Endoscopic Disposable Blades: INCISOR, 5.5mm,EP-1,DSPL BLADE Product #: 7205314. DYO
2009-05-07Smith & Nephew Endoscopic Disposable Blades: NOTCHBLASTER ABR,EP-1,5.5 DSPL Part #: 7205329. DYONIC
2008-08-07DYONICS 25 Fluid Management System bag for enclosure of wireless remote control included with Dispos
2008-08-07DYONICS 25 Fluid Management System Bag for enclosure of wireless remote control included with Dispos
2008-08-07DYONICS 25 Fluid Management System bag for enclosure of wireless remote control included with Dispos
2008-08-07DYONICS 25 Fluid Management System Bag for enclosure of wireless remote control included with Dispos
2007-08-21Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 8 mm x 30 mm, P/N 7211117, Ligament Screw,
2007-08-21Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 9 mm x 30 mm, P/N 7211120, Ligament Screw,
2007-08-21Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 7 mm x 25 mm, P/N 7211113, Ligament Screw
2007-08-21Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 12 mm x 35 mm, P/N 7211127, Ligament Screw
2007-08-21Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, Reverse Thread, 6 mm x 25 mm, P/N 721111
2007-08-21Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 8 mm x 35 mm, P/N 7211118, Ligament Screw,
2007-08-21Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 9 mm x 25 mm, P/N 7211119, Ligament Screw,
2007-08-21Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 10 mm x 25 mm, P/N 7211122, Ligament Screw
2007-08-21Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 11 mm x 35 mm, P/N 7211126, Ligament Screw
2007-08-21Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 10 mm x 20 mm, P/N 72201071, Ligament Scre
2007-08-21Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 9 mm x 35 mm, P/N 7211121, Ligament Screw,
2007-08-21Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 6 mm x 25 mm, P/N 7211110, Ligament Screw
2007-08-21Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 10 mm x 35 mm, P/N 7211124, Ligament Screw
2007-08-21Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 11 mm x 30 mm, P/N 7211125, Ligament Screw
2007-08-21Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 7 mm x 30 mm, P/N 7211115, Ligament Screw,
2007-08-21Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 9 mm x 20 mm, P/N 72201070, Ligament Screw
2007-08-21Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 8 mm x 25 mm, P/N 7211116, Ligament Screw,
2007-08-21Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 6 mm x 20 mm, P/N 7211109, Ligament Screw,
2007-08-21Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 11 mm x 25 mm, P/N 72201072, Ligament Scre
2007-08-21Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, Reverse Thread, 7 mm x 25 mm, P/N 7211114
2007-08-21Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 10 mm x 30 mm, P/N 7211123, Ligament Screw
2007-08-21Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 7 mm x 20 mm, P/N 7211112, Ligament Screw
2007-08-21Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, Reverse Thread, 8 mm x 25 mm, P/N 72201073
2007-08-21Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 8 mm x 20 mm, P/N 72201069, Ligament Screw
2007-04-09Smith & Nephew, 420XL Xenon Light Source, 180 Watt; for endoscopic use. Catalog/Part #72200510; manu
2007-03-01Smith & Nephew Suture Passer 12 inch Part Number 7209166D (refurbished)
2007-03-01Smith & Nephew Suture Passer 12 inch Part Number: 7209166
2007-03-01Smith & Nephew Suture Passer 2 inch Part Number : 7209167
2007-01-19RF Denervation Probe, 5cm, temperature sensing electrodes designed for use in radiofrequency lesion
2007-01-19SOPRO Camera Control Units, NTSC, SV420P; REF (Catalog) #72200505 v1.1; Made in France; Manufactured
2007-01-19SOPRO Camera Control Units, PAL, SV420P, REF (Catalog) #72200506 v1.1; Made in France; Manufactured
2007-01-19RF Denervation Probe, 10 cm, temperature sensing electrodes designed for use in radiofrequency lesio
2007-01-19RF Denervation Probe, 15 cm, temperature sensing electrodes designed for use in radiofrequency lesio
2006-11-01Well Leg Holder With Boot, part of the Supine Universal Hip Distractor System; Ref (Part) #72200632;
2006-09-29TruFit CB Plug Size Code Red, 7mm; quantity 1; Part #605-001-03; product labeled as sterile; manufac
2006-09-29TruFit CB Plug Size Code Blue, 9mm; quantity 1; Part #605-001-05; product labeled as sterile; manufa
2006-09-29TruFit BGS Plug Size Code Blue, 9mm; quantity 1; Part #600-001-05; product labeled as sterile; manuf
2006-09-29TruFit BGS Plug Size Code Red, 7mm; quantity 1; Part #600-001-03; product labeled as sterile; manufa
2006-06-19TriVex 100SV Resector Kit, 4.5 Part Number: 7205876
2006-06-19Dyonics Electroblade 4.5 ELITE, Full Radius, Valleylab Generator- Compatible Part Number: 7209700
2006-06-195.5 mm TRIVEX System Resector Kit (blade and tubing), 3 per box Part Number: 7209515
2006-06-19TriVex 200LV Resector Kit, 5.5 Part Number: 7209271
2006-06-19Dyonics Electroblade 4.5 ELITE, Full Radius, VULCAN Generator-Compatible Part Number: 7209983
2006-06-194.5 mm TRIVEX System Resector Kit (blade and tubing), 3 per box Part Number: 7209514
2006-06-19Dyonics Electroblade 4.5 Full Radius, VULCAN Generator-Compatible Product number: 7209855
2006-06-19Dyonics Electroblade, 4.5 Full Radius, Valleylab Generator-Compatible Part Number: 7205961
2006-05-22Smith & Nephew Hip Positioning System Ref: 72200624 with System Components: Perineal Post 72200631 U
2006-03-24FAST-FIX AB Curved Needle Delivery System, Used for meniscal repair. Product Number: 7209399
2004-10-12Smith & Nephew TRIVEX System Pneumatic Footswitch, Part #7209791; distributed by Smith & Nephew, Inc
2004-02-19Endocoupler , C-Mount 35 mm Focal Length Catalog Number: 7204614, 7204614M, 7204614S
2004-02-19Endocoupler, C-Mount 30 mm Focal Length Catalog Number: 7204823, 7204823S
2004-02-19Endocoupler 18 MM F.L, Autoclavable Catalog Number: 7207905, 7207905S
2004-02-19Endocpir, Zoom for Dyonics 3-Chip Camera Catalog Number: 7205461
2004-02-19Endocoupler C-Mount 35 mmFocal Length Catalog Number: 6900398
2003-10-10Smith & Nephew Endocoupler C-Mount 30mm Focal Length Reference: 7204823 and 7204823S (S indicates u
2003-10-10Smith & Nephew Endocoupler C-Mount 35 mm Focal Length Reference :7204614 and 7204614S (S indicates u