34 results
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20ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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MONTERIS MEDICAL NEUROBLATE SYSTEM, used for MRI-guided neurosurgical ablation.
FDA Recall
Terminated
·Monteris Medical Corp·Product code GEX·October 5, 2017
Persona Partial Knee System, Size 8, Finishing Guide
FDA Recall
Terminated
·Zimmer Biomet, Inc.·Product code HSX·July 5, 2017
Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479
FDA Recall
Terminated
·Baxter Healthcare Corp·Product code FKX·September 1, 2017
EMPOWR PS KNEE(TM) e+, REF 343-13-708, SIZE 8, 13mm, QTY 01, SKY BLUE, STERILE Product Usage The EMPOWR PS Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to conform to ASTM F2695. This insert is posterior stabilized and is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along the lateral condyle.
FDA Recall
Terminated
·Product code JWH·September 15, 2017
EMPOWR PS KNEE(TM) e+, REF 343-19-707, SIZE 7, 19mm, QTY 01, GREY, STERILE Product Usage The EMPOWR PS Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to conform to ASTM F2695. This insert is posterior stabilized and is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along the lateral condyle.
FDA Recall
Terminated
·Product code JWH·September 15, 2017
HomeChoice Automated PD system Model numbers: 5C4471, 5C4471R Product Usage: The HomeChoice Automated Personal Cycler is intended for automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.
FDA Recall
Terminated
·Baxter Healthcare Corporation·Product code FKX·July 5, 2017
HomeChoice Pro Automated PD system Model numbers: 5C8310, 5C8310R Product Usage: The HomeChoice Automated Personal Cycler is intended for automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.
FDA Recall
Terminated
·Baxter Healthcare Corporation·Product code FKX·July 5, 2017
ATAR Reusable Extension Cable, sold under brand names: ATAR Reusable Series, ATAR 53912 Reusable Series, and XI Reusable Series. Model codes: 53912 - MDTS ATAR REUSABLE, 53912A - MDTS ATAR REUSABLE, ATAR MDTS REUSABLE, ATAR-A DARK BLUE REUSABLE, ATAR-MDT REUSABLE, ATAR-MDT2 REUSABLE, ATAR-MDT2S-A, DK BLUE 30CM REUSABLE, ATAR-MDT2S-V WHITE 30CM REUSABLE, ATAR-MDTL REUSABLE, ATAR-MDTR REUSABLE, ATAR-R REUSABLE, ATAR-R T4P REUSABLE, ATAR-R1 REUSABLE, ATAR-RL REUSABLE, ATAR-T REUSABLE, ATAR-V WHITE REUSABLE, ATAR-V2 REUSABLE, XI.A DARK BLUE REUSABLE, XI.MDT REUSABLE, XI.R REUSABLE, XI.V WHITE, REUSEABLE Cable is intended to connect an electrode/lead from a patients or another cable to a diagnostic machine or an external pacemaker
FDA Recall
Terminated
·Oscor, Inc.·Product code IKD·March 31, 2017
ATAR Disposable Extension Cable, sold under brand names: ATAR Disposable Series, ATAR 53912 Disposable Series, and XI Disposable Series. Model codes: ATAR D-A DARK BLUE DISPOSABLE, ATAR D-V WHITE DISPOSABLE, ATAR D-MDT DISPOSABLE, ATAR D-T DISPOSABLE, ATAR D-R DISPOSABLE, ATAR D-RL DISPOSABLE, ATAR D-MDTL DISPOSABLE, ATAR D-MDTS, ATAR D-R1 DISPOSABLE, ATAR D-R NP DISPOSABLE, ATAR D-MDT2, ATAR D-MDTR, ATAR D-R D2P, ATAR D-R T4P, ATAR D-R X2, ATAR D-V2, ATAR D-IS1-2PACE, PACE 101H, PACE 203H WITH ATAR D-MDTS, PACE 203H, PACE 101H WITH ATAR D-T, PACE 300, XI.D-A, DARK BLUE, DISPOSABLE, XI.D-V WHITE DISPOSABLE, XI.D-MDT DISPOSABLE 30 CM, XI.D-T DISPOSABLE, XI.D-RL, XI.D-R DISPOSABLE, 53912D - MDTS ATAR DISPOSABLE Cable is intended to connect an electrode/lead from a patients or another cable to a diagnostic machine or an external pacemaker
FDA Recall
Terminated
·Oscor, Inc.·Product code IKD·March 31, 2017
Oxford Partial Knee System Femoral Slap Hammer Product Usage: Instruments for use with the Oxford Uni Partial Knee System
FDA Recall
Terminated
·Biomet U.K., Ltd. Waterton Industrial Estate Bridgend South Wales United Kingdom·Product code LXH·January 5, 2016
Oxford Unicompartmental Knee Phase 3 Shim Size 3 Product Usage: Instruments for use with the Oxford Uni Partial Knee System
FDA Recall
Terminated
·Biomet U.K., Ltd. Waterton Industrial Estate Bridgend South Wales United Kingdom·Product code LXH·January 5, 2016
Oxford Unicompartmental Knee Phase 3 Shim Size 1 Product Usage: Instruments for use with the Oxford Uni Partial Knee System
FDA Recall
Terminated
·Biomet U.K., Ltd. Waterton Industrial Estate Bridgend South Wales United Kingdom·Product code LXH·January 5, 2016
Oxford Knee System Tibial Resector Body Tube & Guides Product Usage: Instruments for use with the Oxford Uni Partial Knee System
FDA Recall
Terminated
·Biomet U.K., Ltd. Waterton Industrial Estate Bridgend South Wales United Kingdom·Product code LXH·January 5, 2016
Oxford Unicompartmental Knee Phase 3 Tibial Impactor Product Usage: Instruments for use with the Oxford Uni Partial Knee System
FDA Recall
Terminated
·Biomet U.K., Ltd. Waterton Industrial Estate Bridgend South Wales United Kingdom·Product code HWR·January 5, 2016
RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements.
FDA Recall
Terminated
·Mako Surgical Corporation·Product code OLO·December 1, 2017
Oxford Unicompartmental Knee Phase 3 Shim Size 2 Product Usage: Instruments for use with the Oxford Uni Partial Knee System
FDA Recall
Terminated
·Biomet U.K., Ltd. Waterton Industrial Estate Bridgend South Wales United Kingdom·Product code LXH·January 5, 2016
Oxford Partial Knee System Right Medial Tibial Trial Tray Size F Product Usage: Instruments for use with the Oxford Uni Partial Knee System
FDA Recall
Terminated
·Biomet U.K., Ltd. Waterton Industrial Estate Bridgend South Wales United Kingdom·Product code NRA·January 5, 2016
Oxford Partial Knee System Phase 3 Tibial Template Left Medial Size C Product Usage: Instruments for use with the Oxford Uni Partial Knee System
FDA Recall
Terminated
·Biomet U.K., Ltd. Waterton Industrial Estate Bridgend South Wales United Kingdom·Product code NRA·January 5, 2016
Oxford Partial Knee System Right Medial Tibial Trial Tray Size C Oxford Partial Knee System Left Medial Tibial Trial Tray Size C
FDA Recall
Terminated
·Biomet U.K., Ltd. Waterton Industrial Estate Bridgend South Wales United Kingdom·Product code NRA·January 5, 2016
Oxford Partial Knee System Left Medial Tibial Trial Tray Size B Product Usage: Instruments for use with the Oxford Uni Partial Knee System
FDA Recall
Terminated
·Biomet U.K., Ltd. Waterton Industrial Estate Bridgend South Wales United Kingdom·Product code NRA·January 5, 2016