93 results
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21ms
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Sources: EU EUDAMED, US FDA
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Stryker Modular Dual Mobility (MDM) Liner and X3 Acetabular Insert; Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430; Stryker France ZAC Satolos Green Pusignan Av de Satolas Green 69881 Mey Sieu Cedex France The MDM Liner and X3 Acetabular Inserts is a sterile single-use device intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function. This device is intended to be used only with any currently available Howmedica osteonics 22.2 mm and 28 mm diameter femoral heads.
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code LZO·June 3, 2011
Stryker Orthopaedics Rim Impactor Tip Product Usage: Used for MDM surgery.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·January 1, 2014
Stryker Orthopaedics Rim Impactor Tip Product Usage: Used for MDM surgery.
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code HWA·September 30, 2013
Alere iScreen Single Drug Detection (AMT Item Number/ AMT Description): X11-IS1 BUP-DX/ "Alere iScreen" Dx Single Dip Card Single Drug Detection: Buprenorphine (BUP)", X11-IS1 BAR-DX /"Alere iScreen" Dx Single Dip Card Single Drug Detection: Barbiturate (BAR)", X11-IS1 OXY-DX / "Alere iScreen¿ Dx Single Dip Card Single Drug Detection: Oxycodone (OXY)", X11-IS1 BZO-DX / "Alere iScreen" Dx Single Dip Card Single Drug Detection: Benzodiazepine (BZO300)", X11-IS1 MET-DX / "Alere iScreen¿ Dx Single Dip Card Single Drug Detection: Methamphetamine (MET)", X11-IS1 AMP-DX /"Alere iScreen¿ Dx Single Dip Card Single Drug Detection: Amphetamine (AMP)", X11-IS1 MDM-DX / "Alere iScreen¿ Dx Single Dip Card Single Drug Detection: Ecstasy (MDMA)", X11-IS1 MTD-DX /"Alere iScreen¿ Dx Single Dip Card Single Drug Detection: Methadone (MTD)", X11-IS1 MOP-DX/"Alere iScreen¿ Dx Single Dip Card Single Drug Detection: Morphine (MOP)", X11-IS1 THC-DX/"Alere iScreen¿ Dx Single Dip Card Single Drug Detection: Marijuana (THC)", X11-IS1 TCA-DX/ "Alere iScreen¿ Dx Single Dip Card Single Drug Detection: Tricyclic Antidrepessants (TCA)", X11-IS1 PCP-DX /"Alere iScreen¿ Dx Single Dip Card Single Drug Detection: Phencyclidine (PCP)",
FDA Enforcement
Class II
·Terminated·Ameditech Inc·October 7, 2020
Alere iScreen Single Drug Detection (AMT Item Number/ AMT Description): X11-IS1 BUP-DX/ "Alere iScreen" Dx Single Dip Card Single Drug Detection: Buprenorphine (BUP)", X11-IS1 BAR-DX /"Alere iScreen" Dx Single Dip Card Single Drug Detection: Barbiturate (BAR)", X11-IS1 OXY-DX / "Alere iScreen Dx Single Dip Card Single Drug Detection: Oxycodone (OXY)", X11-IS1 BZO-DX / "Alere iScreen" Dx Single Dip Card Single Drug Detection: Benzodiazepine (BZO300)", X11-IS1 MET-DX / "Alere iScreen Dx Single Dip Card Single Drug Detection: Methamphetamine (MET)", X11-IS1 AMP-DX /"Alere iScreen Dx Single Dip Card Single Drug Detection: Amphetamine (AMP)", X11-IS1 MDM-DX / "Alere iScreen Dx Single Dip Card Single Drug Detection: Ecstasy (MDMA)", X11-IS1 MTD-DX /"Alere iScreen Dx Single Dip Card Single Drug Detection: Methadone (MTD)", X11-IS1 MOP-DX/"Alere iScreen Dx Single Dip Card Single Drug Detection: Morphine (MOP)", X11-IS1 THC-DX/"Alere iScreen Dx Single Dip Card Single Drug Detection: Marijuana (THC)", X11-IS1 TCA-DX/ "Alere iScreen Dx Single Dip Card Single Drug Detection: Tricyclic Antidrepessants (TCA)", X11-IS1 PCP-DX /"Alere iScreen Dx Single Dip Card Single Drug Detection: Phencyclidine (PCP)",
FDA Recall
Terminated
·Ameditech Inc·Product code DIO·August 18, 2020
SpeedPass Disposable Suture Lariat with Nitinol Wire 45 Degree Up, QTY. 1, Biomet Sports Medicine, Warsaw, IN 46581. Sterile. Part number 904008. Used to pass suture through tissue.
FDA Recall
Terminated
·Biomet, Inc.·Product code MDM·June 18, 2010
Stryker 9 MM AVS TL Trial Spacer; Catalog number: 48389409. Manufactured by: Stryker Spine SAS, Cestas, France; Distributed in the US by: Stryker Spine, 2 Pearl Court, Allendale, NJ 07401. Intended for use in the thoraco-lumbar spine.
FDA Recall
Terminated
·Stryker Spine·Product code MDM·May 13, 2010
FlexTrayTM Endopath Bariatric Tray, Kit Code TBW70S.
FDA Recall
Terminated
·Ethicon Endo-Surgery·Product code MDM·December 15, 2004
Endopath 5 mm Babcocks with Ratchet Handles (product code 5BB).
FDA Recall
Terminated
·Ethicon Endo-Surgery·Product code MDM·December 15, 2004
FlexTrayTM Endopath Cholecsystectomy Tray, Kit Code TNC06.
FDA Recall
Terminated
·Ethicon Endo-Surgery·Product code MDM·December 15, 2004
FlexTrayTM Endopath Cholecsystectomy Tray, Kit code FDC21
FDA Recall
Terminated
·Ethicon Endo-Surgery·Product code MDM·December 15, 2004
Proximate Linear Cutter with Safety Lock-Out, Reloadable, contains 100 titanium staples with integral knife, Product No. TCT10, staple size: 3 mm x 4.5 mm.
FDA Recall
Terminated
·Ethicon Endo-Surgery·Product code MDM·May 21, 2003
Proximate Linear Cutter with Safety Lock-Out, reloadable, contains 100 titanium staples with integral knife, Product No. #TLC10, staple size: 3 mm x 3.85 mm.
FDA Recall
Terminated
·Ethicon Endo-Surgery·Product code MDM·May 21, 2003
ENDOPATH 10 mm Babcocks with Ratchet Handles (product code 10BB).
FDA Recall
Terminated
·Ethicon Endo-Surgery·Product code MDM·December 15, 2004
FlexTrayTM Endopath Cholecsystectomy Tray, Kit Code TDC09.
FDA Recall
Terminated
·Ethicon Endo-Surgery·Product code MDM·December 15, 2004
FlexTrayTM Endopath Gastric Tray, Kit code KDG05.
FDA Recall
Terminated
·Ethicon Endo-Surgery·Product code MDM·December 15, 2004
FlexTrayTM Endopath Cholecsystectomy Tray, Kit code FDC24
FDA Recall
Terminated
·Ethicon Endo-Surgery·Product code MDM·December 15, 2004
FlexTrayTM Endopath Gastric Tray, Kit code KDG15.
FDA Recall
Terminated
·Ethicon Endo-Surgery·Product code MDM·December 15, 2004
FlexTrayTM Endopath Bariatric Tray Kit,code KBW46
FDA Recall
Terminated
·Ethicon Endo-Surgery·Product code MDM·December 15, 2004
FlexTrayTM Endopath Bariatric Tray, Kit code KBW30.
FDA Recall
Terminated
·Ethicon Endo-Surgery·Product code MDM·December 15, 2004