80 results
·
12ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
REF 800-05-035, ENZTEC FEMORAL IMPACTOR - DJO, (01) 09421028110624 (10) 999999, To be used only with DJO EMPOWR 3D KNEE
FDA Recall
Terminated
·Enztec Limited 26 Dakota Crescent, Sockburn Christchurch New Zealand·Product code HWA·August 16, 2019
Linear Straight Broach Handle (Rasp Handle) (Greatbatch Part # 510397; DJO Surgical Inc., # 803-03-159) and EZ Clean" Linear Broach Handle Greatbatch Part # T11824, DJO Surgical Inc. # 803-03-059).
FDA Enforcement
Class II
·Terminated·Greatbatch Medical·May 17, 2017
VenaFlow Elite 30B-B and 30BI-B Product Usage: The VenaFlow Elite System is a compression pump used for the prevention of Deep Vein Thrombosis.
FDA Recall
Terminated
·DJO, LLC·Product code JOW·May 28, 2013
RSP Baseplate Rim Planer (Size 32, 36, 40): DJO Surgical Instruments and Instrument Cases DJO surgical Encore Medical, L.P. 9800 Metric Blvd, Austin, TX 78758 Contact information: DJO Surgical, ATTN: Customer Service, 9800 Metric Blvd, Austin, TX 78758, 1-800-456-8696 The Baseplate Rim Planer is used to prepare the bone around the peripheral rim of the reamed socket. It has a spring loaded alignment pin on the proximal (cutting) end used in both alignment of the planer and as an indication that the planer has been seated fully.
FDA Recall
Terminated
·Product code LXH·September 28, 2011
RSP Humeral Socket Reamer (Size 32 SML): DJO Surgical Instruments and Instrument Cases DJO surgical Encore Medical, L.P. 9800 Metric Blvd, Austin, TX 78758 Contact information: DJO Surgical, ATTN: Customer Service, 9800 Metric Blvd, Austin, TX 78758, 1-800-456-8696. The product is intended to be used to ream prepare the humeral bone for accepting the implant. It has a spring loaded alignment pin on the proximal (reaming) end used in both alignment of the reamer and as an indication that the reamer has been seated fully.
FDA Recall
Terminated
·Product code LXH·September 28, 2011
REF 800-05-035, ENZTEC FEMORAL IMPACTOR - DJO, (01) 09421028110624 (10) 999999, To be used only with DJO EMPOWR 3D KNEE
FDA Enforcement
Class II
·Terminated·Enztec Limited·February 3, 2021
CLP Instrumentation Removal Hook, distributed by DJO Surgical, manufactured by Encore Medical, Austin, TX.
FDA Recall
Terminated
·Product code HWB·November 10, 2010
Linear Straight Broach Handle (Rasp Handle) (Greatbatch Part # 510397; DJO Surgical Inc., # 803-03-159) and EZ Clean" Linear Broach Handle Greatbatch Part # T11824, DJO Surgical Inc. # 803-03-059).
FDA Recall
Terminated
·Greatbatch Medical·Product code HTQ·April 23, 2017
DJO EMPOWR KNEE LOCKING TIBIAL PUNCH GUIDE, REF 801-05-042, NON STERILE, Qty 1 For use in orthopedic surgery.
FDA Recall
Terminated
·Product code JWH·December 12, 2017
FMP X-alt Acetabular Liner This acetabular liner is intended for use with DJO Surgical hip systems. It is used with an acetabular shell to replicate the kinematics of a natural hip.
FDA Recall
Terminated
·Djo Surgical·Product code LPH·February 7, 2014
Monode, Shortwave Accessory Model #: 02200002 Used in conjunction with the Intelect Shortwave Diathermy 100 and Intelect Shortwave Diathermy 400 units. For the clinical application of electromagnetic energy in the radio frequency of 27.12 megahertz to generate deep heat within body tissues.
FDA Recall
Terminated
·DJO, LLC·Product code IMJ·August 21, 2015
This is an accessory to Intelect Advanced, Intelect Mobile, Intelect Neo, and V-Sonic devices. NYLATEX WRAP - Product Usage: are intended to be used based on the devices associated with them. Nylatex wraps are composed of nylon and natural rubber and are accessories used to secure electrodes or thermal therapy to a patient.
FDA Recall
Terminated
·DJO, LLC·Product code IMF·June 25, 2018
Henry Schein One Step + DOA Cup (AMT Item Number/ AMT Description): 570-1066 / "Henry Schein OneStep+ DOA Cup 14 Panel AMP500/BAR/BUPG/BZO/COC150/MDMA/MET500/MOP/MTD/OXY/PCP/PPX/TCA/THC (Bl, Cr, Ni, pH, SG)",
FDA Recall
Terminated
·Ameditech Inc·Product code LDJ·August 18, 2020
Henry Schein One Step + DOA Cup (AMT Item Number/ AMT Description): 570-1066 / "Henry Schein OneStep+ DOA Cup 14 Panel AMP500/BAR/BUPG/BZO/COC150/MDMA/MET500/MOP/MTD/OXY/PCP/PPX/TCA/THC (Bl, Cr, Ni, pH, SG)",
FDA Enforcement
Class II
·Terminated·Ameditech Inc·October 7, 2020
Turon Shoulder System Instrumentation, Turon Trial Humeral Neck, DJO Surgical
FDA Recall
Terminated
·Product code KWS·November 5, 2010
Turon Shoulder System Instrumentation, Turon Humeral Head Trials, DJO Surgical
FDA Recall
Terminated
·Product code KWS·November 5, 2010
Turon Shoulder System Instrumentation, Turon Trial Pegged Glenoid, DJO Surgical
FDA Recall
Terminated
·Product code KWS·November 5, 2010
DJO EMPOWR KNEE LOCKING TIBIAL PUNCH GUIDE, REF 801-05-042, NON STERILE, Qty 1 For use in orthopedic surgery.
FDA Enforcement
Class II
·Terminated·Encore Medical, Lp·January 17, 2018
AltiVate Reverse Small Socket Insert, 44mm Semi Constrained - E-Plus, Part Number: 509-03-044 - Product Usage: Per IFU, DJO Surgical shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indication for use.
FDA Enforcement
Class II
·Terminated·Encore Medical, LP·October 28, 2020
djo surgical Screw 6.5 mm, Sz 25mm, low profile. Product is intended for the fixation of the acetabular shell or fracture repair
FDA Enforcement
Class II
·Terminated·Encore Medical, Lp·August 15, 2012