58 results
·
13ms
·
Sources: EU EUDAMED, US FDA
Multi Vector Distractor Pin Holding Clamp, limited bone stock The holding clamp is part of the Multi Vector Distractor which cis used for mandibular bone lengthening, including conditions such as congenital mandibular deficiencies or post-traumatic defects. The Multi Vector Distractor can be utilized to perform bone transport procedures as an alternative to bone grafts and free flaps.
FDA Recall
Terminated
·Synthes USA HQ, Inc.·Product code DZL·May 31, 2013
BIOMET 3i GS300 GOLD SLOTTED SCREW-3mm, STERILE, Rx Only. Made in USA. Lots 868517, 865348, and 868515. BIOMET 3i, 4555 Riverside Dr., Palm Beach Gardens, FL.
FDA Recall
Terminated
·Biomet 3i, LLC·Product code DZL·October 6, 2009
Synthes Multi-Vector Distractor Body, Part Number 487.931. For mandibular bone lengthening.
FDA Recall
Terminated
·Synthes USA HQ, Inc.·Product code DZL·January 11, 2013
BIOMET MICROFIXATION "1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, QTY 1, 1.5 X 4MM TITANIUM. REF 91-1504 1 COUNT and REF 95-1504 - 5 PACK. BIOMET MICROFIXATION 1520 TRADEPORT DRIVE, JACKSONVILLE, FL 32218 USA, WWW.BIOMETMICROFIXATION.COM. Intended to aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal system.
FDA Recall
Terminated
·Biomet Microfixation, Inc.·Product code DZL·March 17, 2010
Synthes Multi-Vector Distractor, Multi-axial Mandible Distractor (Right), Part Number 487.966. For mandibular bone lengthening.
FDA Recall
Terminated
·Synthes USA HQ, Inc.·Product code DZL·January 11, 2013
Synthes Multi-Vector Distractor - Multi-axial Mandible Distractor (Left), Part Number 487.967. For mandibular bone lengthening.
FDA Recall
Terminated
·Synthes USA HQ, Inc.·Product code DZL·January 11, 2013
Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, 400.833E Product Usage: The Low Profile Neuro Plating System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
FDA Recall
Terminated
·Synthes (USA) Products LLC·Product code DZL·February 23, 2016
Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, 400.833E Product Usage: The Low Profile Neuro Plating System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
FDA Recall
Terminated
·Synthes (USA) Products LLC·Product code DZL·February 23, 2016
DAL-RO Abutment Dental implants
FDA Recall
Terminated
·Biomet 3i, LLC·Product code DZE·November 25, 2015
DAL-RO Threaded Female Dental implants
FDA Recall
Terminated
·Biomet 3i, LLC·Product code DZE·November 25, 2015
VER2 D8L OFFSET RASP HANDLE, RT Nonsterile
FDA Recall
Terminated
·Zimmer, Inc.·Product code LXH·July 23, 2014
DAL-RO Housing, Female Assembly Dental implants
FDA Recall
Terminated
·Biomet 3i, LLC·Product code DZE·November 25, 2015
VER2 DBL OFFSET RASP HANDLE, LT Nonsterile
FDA Recall
Terminated
·Zimmer, Inc.·Product code LXH·July 23, 2014
Vl DBL OFFST WI LRG STPL, RT Nonsterile
FDA Recall
Terminated
·Zimmer, Inc.·Product code LXH·July 23, 2014
VI DBL OFFST W/ LRG STPL, LT Nonsterile
FDA Recall
Terminated
·Zimmer, Inc.·Product code LXH·July 23, 2014
Endoscopic Cleaning Brush, single use, sold in kits and labeled as the following: a. Item Number DYK1002DCB, BRUSH, CLEANING, DOUBLE ENDED, W/ HANDLE - 300 EA/CS, 50EA/BX, 6BX/CS; b. Item Number DYK1002DBDE, BRUSH, CLEANING, DBL, DIF ENDS - 500 EA/CS, 50 EA/BX, 10 BX/CS; c. Item Number DYK1002DBSE, BRUSH, CLEANING, DBL, SAME END - 500 EA/CS, 50 EA/BX, 10 BX/CS; d. Item Number DYK1002SBC, BRUSH, CLEANING, SINGLE END - 500 EA/CS, 50 EA/BX, 10 BX/CS
FDA Recall
Terminated
·Medline Industries Inc·Product code MNL·June 15, 2018
Locking Tear-Away Sheath Introducer Product Line. ACCUGUIDE SINGLE LUMEN 4FR PICC P460K 5/; P560K PICC 5FR W/INTRO KIT; MTI451845 4.5FR MINI T/A; MTI551845 5.5FR MINI TA; MTI651845 6.5FR MINI T/A; P460OTW SNGL LUM PICC W/MTI; P4552K DBL LUM PICC INTRO KIT; P5552K DBL LUM PICC INTRO KIT; P4552KOTW DBL LUM OTW PICC INTRO KIT LF; LOCKING T/A INTRODUCERS 11FR; INTRADYN TEAR-AWAY INTRODUCER 4F; INTRADYN TEAR-AWAY INTRODUCER 5F; INTRADYN TEAR-AWAY INTRODUCER 6F; INTRADYN TEAR-AWAY INTRODUCER 7F; INTRADYN TEAR-AWAY INTRODUCER 8F; INTRADYN TEAR-AWAY INTRODUCER 9F; INTRADYN TEAR-AWAY INTRODUCER 10F; INTRADYN TEAR-AWAY INTRODUCER 11F; INTRADYN TEAR-AWAY INTRODUCER 12F; INTRADYN TEAR-AWAY INTRODUCER 15F; INTRADYN TEAR-AWAY INTRODUCER 16F; 23HI120 12F X 23CM HEMO INTRO; 23HI130 13F X 23CM HEMO INTRO; 30STA8 8FR X30CM T/A INTRO -NJ*; 30STA9 9FR X 30CM SHEATH -NJ*; 30STA10 10FR X 30CM T/A INTRO -NJ*; 30STA12 12FR X 30CM T/A INTRO -NJ*; 30STA16 16FR X 30CM SHEATH; BOSTON SCI 16F X 9.54 STEP DIL/SHEATH; 45STA9 45CM T/A INTRODUCER -NJ*; LUTHER 6F - T/A ASSM CLIP; 10HI14038 14F X 11CM HEMO W/WI; BOSTON SCI 12FX 21.35 DIL/SHEATH; 10HI12038 12F X 11CM HEMO W/WI; 10HI13038 13F X 11CM HEMO W/WI; BOSTON SCI 9F X 9.54 STEP DIL/SH; BOSTON SCI 9F X 15.44 STEP DIL/SH; BOSTON SCI 9F X 21.35 STEP DIL/SH; BOSTON SCI 11F X 9.54 STEP DIL/SH; BOSTON SCI 11F X 15.44 STEP DIL/SH; BOSTON SCI 12F X 9.54 DIL/SHEATH; BOSTON SCI 12F X 15.44 DIL/SHEATH; BOSTON SCI 14F X 9.54 DIL/SHEATH; BOSTON SCI 14F X 15.44 DIL/SHEATH; BOSTON SCI 16F X15.44 DIL/SHEATH; 30STA15 15FR LONG TA INTRODUCR; 30STA11 11FR LONG TA INTRODUCR -NJ*; CARDIAC PACEMAKER T/A SHEATH; 14FR TA DILATOR/SHEATH-BULK; 12FR INTRODUCER TEAR AWAY BNS; 12FR TA DIL/SHEATH LC; 8FR TA SHEATH; 10FR TA SHEATH; 16FR TA SHEATH; 8/10FR LOCK T/A INTRO STEPPED; 6FR T/A DILATOR/SHEATH; 6FR LOCKING T/A INTRO ASSY; 14FR X 143MM LOCKING T/A INTRODUCERS; PTFE 4.5 FR BARD ACCESS INTRODUCERS; PTFE 6.0 FR BARD ACCESS INTRODUCERS; 7F LOCKING INTRO SYSTEM; 8 (O/S) FR. LOCKING TEARAWAY INTRODUCER; 9 FR (0/S) LOCKING INTRO SYSTEM; 12F LOCKING INTRO SYSTEM; 14FR LOCKING T/A INTRODUCER; 10FR X 18 CM LOCKING T/A INTRODUCER; 14FR X 12MM LOCKING T/A INTRODUCER; 10.5FR X 18CM LOCKING T/A INTRODUCER; 10FR X 23CM LOCKING T/A INTRODUCER; 10FR LOCKING TEAR-AWAY INTRODUCERS; INTRADYN TEAR-AWAY INTRODUCER 10.5F; 30STA14 14FR X 30CM T/A INTRO -NJ*; BOSTON SCIENTIFIC 15FR LOCKING TEARAWAY; CELSA 5FR LOCKING T/A INTRODUCER; CORDIS 4'' BLUNT TIP T/A SHEATH; MEDTRONIC PS MED INTRO ASM 14F -NJ*; MEDTRONIC PS MED INTRO ASM 15F.
FDA Recall
Terminated
·B. Braun Medical, Inc.·Product code DYB·May 27, 2005
CHS Custom Convenience Kit- (1) DT SCATPAD, DBL. TAPE, 12.5 X 16.5 Product Number: SEPA 402 (2) SCATPAD, 11 X 34 Product Number: SPA502
FDA Recall
Terminated
·Custom Healthcare Systems, Inc.·Product code LRO·August 13, 2018
GALT VALVED TEARAWAY KIT GALT VTI w/ Sideport Stainless Steel Dbl Flex. J-St RX ONLY UNITS 1 STERILE EO Product Usage: Used in percutaneous procedures to introduce catheters and other intravascular devices into the peripheral vasculature.
FDA Recall
Terminated
·Galt Medical Corporation·Product code DYB·July 25, 2014
Hemodialysis Catheters and PICCs: Product identification: MCDLTSL24P (SF X 24CM LT HEMO-CATH), MC061422 (14FX15CM SLX DBL LMN ST CATH), MRCTP41017 (4F X 55CM SINGLE CT PICC), MRCTP52007 (5F DUAL PRO-PICC NURSING TRAY), MRCTP52010 (5F DUAL PRO-PICC MAX BARR TRAY), MR81013106MB (3FX60CM SGL TAPRLS VASCU-PICC). Intended uses: To attain long-term vascular access for hemodialysis and apheresis. The Medcomp SLX Silicone Double Lumen Catheter is designed for acute hemodialysis and apheresis. The Pro-PICC CT catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injection of contrast media, and allows for central venous pressure monitoring. The Peripherally Inserted Central Vein Access Catheters are designed for Long or Short- Term peripheral access to the central venous system for intravenous therapy and blood sampling, and allows for central venous pressure monitoring.
FDA Recall
Terminated
·Medical Components, Inc dba MedComp·Product code LFJ·January 21, 2015