18 results
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Sources: EU EUDAMED, US FDA
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Tibiaxys Ankle Arthrodesis Plate Compression Guide, Model #159635, part # 159 635, Batch #: EAHZ, EAJ1, ELGV, ENQE & ENQH. Product Usage: The Compression guide is a re-usable instrument used in the implantation of the Tibiaxys product. The Tibiaxys system is intended for fixation of bone fractures or for bone reconstruction (arthrodesis, osteotomies, and fractures of ankle joint, distal tibia and fibula).
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code OYK·November 17, 2011
- Average Medium Blade 9mm x 25mm x 0.38mm Ref. 2296-3-111 Lot 122590, 122447 - Cannulated Drill Bit, Quick Coupling, For 3.5 & 4mm Cannulated Screws, 1.35mm Cannulation 2.7mm x 160mm Ref. 310.67 Lot 122289 - Hall MicroChoice, Oscillating Blade, Fine, Flat, Stainless Steel 5.5mm x 12.0mm x 0.4mm Ref. 5023-160 Lot 123353 - Hall MicroChoice, Oscillating Saw Blade, Fine, Flat, Stainless Steel 5.5mm x 18.5mm x 0.4mm Ref. 5023-162 Lot 123353 - Hall MicroChoice, Sagittal Saw Blade, Fine 4.5mm x 25.5mm x 0.4mm Ref. 5023-139 Lot 122454 - Hall MicroChoice, Sagittal Saw Blade, Stainless Steel 9.5mm x 25.5mm x 0.4mm Ref. 5023-138 Lot 122454, 123353 - Large Sagittal Saw Blade 25mm x 89.5mm x 0.89mm Ref. 2108-102 Lot 122490 - Micro Choice Oscillating Saw Blade 5.5mm x 18.5mm x 0.40mm Ref. KM-3000 Lot 122440 - Micro Oscillating and Sagittal Saw Blade 9.0mm x 25mm x 0.51mm Ref. 2296-33-521 Lot 122609, 122429 - Oscillating and Sagittal Saw Blade 9.0mm x 31mm x 0.51mm Ref. 2296-33-225 Lot 122347 - Oscillating Sagittal Blade 9mm x 31mm x .38mm Ref. 2296-3-525 Lot 123263 - Oscillating Saw Blade 9.0mm x 25.0mm x .38mm Ref. SP-511 Lot 122631 - Oscillating Saw Blade 9mm x 25mm x .38mm Ref. 2296-3-511 Lot 122447 - Reciprocating Saw Blade, Double Sided Fixed Point Travel: 3.56mm 70mm x 12.5mm x 0.64mm Ref. 227-96-275 Lot 122490 - Round Fast Cutting Stainless Steel Bur, 8 Flute 4.8mm Ref. 1608-6-139 Lot 122447 - Sagittal Saw Blade 4.5mm x 25.4mm Ref. KM-3102 Lot 122465 - Small Oscillating Blade 9.0mm x 31.0mm x .4mm Ref. 2296-3-125 Lot 122447 - Small Oscillating Saw Blade 5.5mm x 11.5mm x 0.38mm Ref. 2296-3-410 Lot 122429 - Small Oscillating Saw Blade 5.5mm x 18.0mm x 0.4mm Ref. 2296-3-212 Lot 122511 - Small Oscillating Saw Blade 5.5mm x 18mm x 0.38mm Ref. 2296-3-412 Lot 122447 - Small Oscillating Saw Blade 7mm x 18.5mm x 0.38mm Ref. 2296-3-114 Lot 122429, 122511 - Small Oscillating Saw Blade 9.0mm x 31mm x 0.4mm Ref. 2296-3-225 Lot 122590, 122447 - Small Sagittal Saw Blade, Fine Tooth 9.5mm x 25.5mm x 0.4mm Ref. ZS-338 Lot 122647 - System 4 & System 2000 Sagittal Saw Blade 12.5mm x 81.5mm x 1.19mm Ref. 2108-152 Lot 122490 - System 4, System 2000 & EHD Sagittal Saw Blade, Dual Cut 1.27mm x 11mm x 90mm Ref. 4111-127-090 Lot 123263 - System 4, System 2000 & EHD Sagittal Saw Blade, Dual Cut 18mm x 75mm x 0.89mm Ref. 4118-089-075 Lot 123263 - System 4, System 2000 & EHD Sagittal Saw Blade, Dual Cut 25mm x 90mm x 1.27mm Ref. 4125-127-090 Lot 122347 - System 4, System 2000 & EHD Sagittal Saw Blade, Dual-Cut 18mm x 90mm x 1.35mm Ref. 4118-135-090 Lot 122347 Surgical instrument motors and accessories/attachments
FDA Enforcement
Class II
·Terminated·Surgical Instrument Service And Savings, Inc.·July 10, 2013
DCI Equipment Track Mount Light Assembly, 110v
FDA Recall
Terminated
·Dental Equipment LLC·Product code EAZ·May 1, 2007
bluephase style Light probe Pin-point 6>2 mm black REF # 636 241. The accessory is a pin point light probe, an accessory to a dental curing light Ultraviolet activator for polymerization for use during dental curing.
FDA Recall
Terminated
·Ivoclar Vivadent, Inc.·Product code EBZ·April 14, 2014
LuxStar Dental Light have the following Agency model or Catalog Model numbers as ML1000, OL1000, CL1000, WL1000, CB1000, TL1000, and UL1000. The product is labeled in part: " Marus Dental***Mfg By: Dental Equipment LLC.***705 S. Springbrook Rd Building C Newberg, Oregon, 97132 USA***Dental Light***MN ML1000***". Product Usage: The intended use of the dental light is used for illuminating the oral cavity during the performance of dental procedures.
FDA Recall
Terminated
·Dental Equipment LLC·Product code EAZ·May 27, 2011
DISPOSA-SHIELD. The Disposable Curing Shield For Your Curing Light. The disposable Disposa-Shield are sold in different sizes from 6 mm, 8 mm, 9 mm, 11 mm and 13 mm. The devices are Intended to be place over the tip of a dental curing light wand to protect the doctor's and patient's vision from exposure to high intensity light; soften contact of curing light against the teeth, and keep light guide cleaner, therefore maintaining good levels of light intensity for proper and fast curing The label of the O'Ryan Disposa-Shield listed the following: -Protect Doctor's And Patient's Vision From Exposure To High Intensity Light. -Soften Contact Of Light Guide Against Teeth. -Keep Light Guide Cleaner, Therefore, Maintaining Good Levels Of Light Intensity For Proper And Faster Curing. There are 25 devices per clear plastic bag when distributed in bulk and two devices per clear plastic zip lock type bag when distributed with curing lights. The "Sterilize Before Use" label is placed on a clear plastic bag containing 25 pieces of Disposa-Shield units distributed with all shipment of bulk Disposa-Shield. The "Sterilize Before Use" label is NOT placed on plastic zip lock type bag when distributed with two Disposa-Shield with curing lights. The product is labeled in parts: "***DISPOSA-SHIELD***The Disposable Curing Shield For Your Curing Light***STERILIZE BEFORE USE***O'RYAN INDUSTRIES***INSTRUCTIONS FOR INSTALLING DISPOSA-SHIELD***1. Remove and dispose of old DISPOSA-SHIELD***2. Sterilize wand tip***3. Simply stretch new DISPOSA-SHIELD over tip of wand***800-426-4311 or (360) 892-0447***(360) 892-6742 Fax***[email protected]***'. The private label is labeled in parts: "***DISPOSA-SHIELD***The Disposable Curing Shield For Your Curing Light***ALMORE INTERNATIONAL , INC***STERILIZE BEFORE USE***".
FDA Recall
Terminated
·O'Ryan Industries Inc·Product code EBZ·April 23, 2012
Helios HL3T and HLT Track Mounted Dental Lights Product Usage: The product is intended for use by dental professionals to illuminate the oral cavity while performing examinations and dental procedures.
FDA Recall
Terminated
·Pelton & Crane Marus DCI Equipment KaVo·Product code EAZ·March 8, 2016
Brand Name: EmpowerCT/EmpowerCTA Injector System Ceiling Column Accessory; Common/Usual Name: CT Injector System Ceiling Column Accessory, Catalog Number 9886S. Ceiling Column Accessory: The CT and CTA Injector Systems employs an Articulating Arm that mounts to the Ceiling Column Accessory, which are designated as 9886S (11.25''), M (21.50''), and L (34.50''), i.e. 9886L.
FDA Recall
Terminated
·E-Z-EM, Inc·Product code JAK·December 3, 2004
Titan 3 5K Low-Speed Motor - Star Titan 3, 5,000 rpm- Lube Free
FDA Recall
Terminated
·Dental EZ Stardental Division·Product code EFA·August 11, 2010
StarDental Classique(TM) Diamond Dental Bur. Used for specific applications in dental procedures.
FDA Recall
Terminated
·Dental EZ Stardental Division·Product code NME·May 28, 2013
Brand Name of Device: EmpowerCT/EmpowerCTA Injector System Ceiling Column Accessory; Common/Usual Name: CT Injector System Ceiling Column Accessory, Catalog Number 9886L. Ceiling Column Accessory: The CT and CTA Injector Systems employs an Articulating Arm that mounts to the Ceiling Column Accessory, which are designated as 9886S (11.25''), M (21.50''), and L (34.50''), i.e. 9886L.
FDA Recall
Terminated
·E-Z-EM, Inc·Product code JAK·December 3, 2004
Brand Name: EmpowerCT/EmpowerCTA Injector System Ceiling Column Accessory; Common/Usual Name: CT Injector System Ceiling Column Accessory, Catalog Number 9886M. Ceiling Column Accessory: The CT and CTA Injector Systems employs an Articulating Arm that mounts to the Ceiling Column Accessory, which are designated as 9886S (11.25''), M (21.50''), and L (34.50''), i.e. 9886L.
FDA Recall
Terminated
·E-Z-EM, Inc·Product code JAK·December 3, 2004
StarDental Classique(TM) Diamond Dental Bur. Used for specific applications in dental procedures.
FDA Enforcement
Class II
·Terminated·Dental EZ Stardental Division·June 19, 2013
Titan T 5K Motor Product Usage: Low-speed motor is used with various attachments to perform a variety of dental procedures including caries removal, finishing, polishing, pin setting and prophy.The motor has a speed range of 100 to 5000 rpm capability.
FDA Recall
Terminated
·Dental EZ Group Star Dental Division·Product code EFA·June 13, 2014
Titan T 5K Motor Product Usage: Low-speed motor is used with various attachments to perform a variety of dental procedures including caries removal, finishing, polishing, pin setting and prophy.The motor has a speed range of 100 to 5000 rpm capability.
FDA Enforcement
Class II
·Terminated·Dental EZ Group Star Dental Division·July 23, 2014
Portable HDX Intraoral Dental X-Ray. Extraoral Source X-ray System. Part number 300020
FDA Recall
Terminated
·Den-Tal-Ez Inc, Star Dental Div·May 16, 2003
EZ Derm Porcine Xenograft, labeled as the following: a. EZ Derm 3x4 (8x10 cm) Non-Perforated, Part Number: 131703-03; b. EZ Derm 7 x 18 (17 x 46 cm) Non-Perforated, Part Number: 131704-03; c. EZ Derm 2 x 2 (5 x 5 cm) Non-Perforated, Part Number: 131705-03; d. EZ Derm 3 x 48 (8 x 122 cm) Perforated, Part Number: 131710-03; e. EZ Derm 3 x 24 (8 x 61 cm) Perforated, Part Number: 131711-03; f. EZ Derm 3 x 12 (8 x 30 cm) Perforated, Part Number: 131712-03; g. EZ Derm 3 x 4 (8 x 10 cm) Perforated, Part Number: 131713-03; h. EZ Derm 7 x 18 (17 x 46 cm) Perforated, Part Number: 131714-03; i. EZ Derm 2 x 2 (5 x 5 cm) Perforated. Part Number: 131715-03 Product Usage: EZ Derm is a porcine derived xenograft in which the collagen has been cross linked with an aldehyde. EZ Derm (porcine xenograft) can be used for partial thickness skin loss injuries. Use of EZ Derm for burns, donor sites and chronic vascular ulcers reduces pain and fluid loss. EZ Derm can also be used as a temporary cover, or test graft, prior to auto grafting and as a protective covering over perforated auto grafts.
FDA Recall
Terminated
·Molnlycke Health Care, Inc·Product code KGN·March 26, 2019
EZ Derm Porcine Xenograft, labeled as the following: a. EZ Derm 3x4 (8x10 cm) Non-Perforated, Part Number: 131703-03; b. EZ Derm 7 x 18 (17 x 46 cm) Non-Perforated, Part Number: 131704-03; c. EZ Derm 2 x 2 (5 x 5 cm) Non-Perforated, Part Number: 131705-03; d. EZ Derm 3 x 48 (8 x 122 cm) Perforated, Part Number: 131710-03; e. EZ Derm 3 x 24 (8 x 61 cm) Perforated, Part Number: 131711-03; f. EZ Derm 3 x 12 (8 x 30 cm) Perforated, Part Number: 131712-03; g. EZ Derm 3 x 4 (8 x 10 cm) Perforated, Part Number: 131713-03; h. EZ Derm 7 x 18 (17 x 46 cm) Perforated, Part Number: 131714-03; i. EZ Derm 2 x 2 (5 x 5 cm) Perforated. Part Number: 131715-03 Product Usage: EZ Derm is a porcine derived xenograft in which the collagen has been cross linked with an aldehyde. EZ Derm (porcine xenograft) can be used for partial thickness skin loss injuries. Use of EZ Derm for burns, donor sites and chronic vascular ulcers reduces pain and fluid loss. EZ Derm can also be used as a temporary cover, or test graft, prior to auto grafting and as a protective covering over perforated auto grafts.
FDA Enforcement
Class II
·Terminated·Molnlycke Health Care, Inc·May 8, 2019