349 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Multi-Drug iCup Drug Screen Test Cup. Part Number DUE-1127-022-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
FDA Recall
Terminated
·Biosite Inc·Product code DKZ·April 27, 2009
Artiste MV SA Linear Accelerator with syngo RT Therapist Version 4.1 build 67 and build 122. Manufactured by Siemens Medical Solutions Oncology Care Systems, Concord, CA.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IYE·October 23, 2008
Zimmer Kinectivo Technology Modular Neck, BB, 12/14 neck taper, sterile, Zimmer, Warsaw, IN; Catalog Number: 00-7848-022-01. Orthopedic implant used in total hip arthroplasty.
FDA Recall
Terminated
·Zimmer Inc.·Product code LPH·May 29, 2009
Titanium Orthos Brackets, an orthodontic bracket. 022 +9/+9/0, Part Number 449-6212, Lot Number 121359169. A fixed attachment on a tooth which holds an archwire during orthodontic treatment.
FDA Enforcement
Class II
·Terminated·Ormco/Sybronendo·April 9, 2014
Comprehensive Shoulder System, 4 mm, 122 mm long, Primary Shoulder Stem, Ti-6Al-4V, Standard Length Porous Plasma. Shoulder joint replacement components include humeral stems, humeral heads, and glenoid components.
FDA Enforcement
Class III
·Terminated·Biomet, Inc.·June 17, 2015
Skytron Infinity Series surgical light, 4 bulbs in 1 - 22' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF54, IF54EL, IF54LH and IF54S.
FDA Recall
Terminated
·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007
Margron DTC Hip Replacement System; Margron hip - Femoral stem 2+2, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-022. Product is used for Orthopedic surgery.
FDA Recall
Terminated
·Portland Orthopaedics Pty, Ltd.
1 South Street, Suite 3, Level 5
Saint George Hospital
Kogarah Australia·Product code MEH·January 11, 2008
Triathlon PKR Insert X3 #1 LM/RL - 8mm, 5630-G-108, Lot code NXDMEE Triathlon PKR Insert X3 #1 RM/LL - 12mm, 5630-G-122, Lot Code M8JMEE Intended Use: - Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis - Revision of previous unsuccessful surgical procedures, either involving, or not involving, previous use of a unicompartmental knee prosthesis - As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis, where bone stock is of poor quality or inadequate for other reconstructive techniques as indicted by deficiencies of the femoral condyle/tibia plateau. These components are intended for implantation with bone cement. Stryker Orthopaedics; Howmedica Osteonics Copr. 325 Corporate Drive Mahwah, NJ 07430
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code HRY·November 25, 2008
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Microbore, 122 Inch. 1 unit per pouch; 50 pouches per case
FDA Enforcement
Class II
·Terminated·ICU Medical Inc·October 23, 2019
Zimmer Reconstruction System Tenaculum Right Tine Straight 9 inch, Item # 00-1179-022-00, Zimmer Inc., Warsaw, IN. Intended to temporarily reduce pelvic fractures for fixation during reconstructive surgery.
FDA Recall
Terminated
·Zimmer Inc.·Product code HWN·February 16, 2010
Pursuit ureteral dilation balloon catheters, 6 mm x 4 cm. Order # PAB-050080-6-4.0
FDA Recall
Terminated
·Cook Urological, Inc.·Product code EZN·January 22, 2003
Pursuit ureteral dilation balloon catheters, 6 mm x 8 cm. Order # PAB-050080-6-8.0
FDA Recall
Terminated
·Cook Urological, Inc.·Product code EZN·January 22, 2003
Boston Medical Products Otocell Ear Wick 15 mm, sterile Ref: EW-0915
FDA Recall
Terminated
·Boston Medical Products, Inc.·January 22, 2003
SmartBlock Pain Management System, Part numbers P49524, P49534, P49624, and P49634.
FDA Recall
Terminated
·Hsmg, Inc. D/b/a Smartinfuser Usa·Product code MEB·January 8, 2009
Comprehensive Shoulder System, 4 mm, 122 mm long, Primary Shoulder Stem, Ti-6Al-4V, Standard Length Porous Plasma. Shoulder joint replacement components include humeral stems, humeral heads, and glenoid components.
FDA Recall
Terminated
·Biomet, Inc.·Product code MBF·April 16, 2015
Titanium Orthos Brackets, an orthodontic bracket. 022 +9/+9/0, Part Number 449-6212, Lot Number 121359169. A fixed attachment on a tooth which holds an archwire during orthodontic treatment.
FDA Recall
Terminated
·Ormco/Sybronendo·Product code EJF·March 25, 2014
SmartInfuser PainPump, part numbers P49230, P49220, P49224-D, P49224N, P49230-D and P49234.
FDA Recall
Terminated
·Hsmg, Inc. D/b/a Smartinfuser Usa·Product code MEB·January 8, 2009
VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators; REF/CATALOG # 684 4055, IVD --- COMMON/USUAL NAME: VITROS Vitamin D Calibrators -- Ortho-Clinical Diagnostics High Wycombe HP12 4DP, UK --- For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic Systems, and the VITROS 5600 Integrated System for the quantitative measurement of total 25-OH Vitamin D in human serum.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code JIT·January 15, 2014
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Microbore, 122 Inch. 1 unit per pouch; 50 pouches per case
FDA Recall
Terminated
·ICU Medical Inc·Product code FRN·July 29, 2019
Abbott Accelerator a3600, ARCHITECT cSystem c8000/c16000 Interface Module, Part Numbers: ACP-208-00 - Product Usage: The FlexLab (aka Accelerator a3600) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation.
FDA Enforcement
Class II
·Terminated·Inpeco S.A.·May 20, 2020