132 results · 13ms · Sources: EU EUDAMED, US FDA

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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 Recall
Terminated ·Enztec Limited 26 Dakota Crescent, Sockburn Christchurch New Zealand·Product code HWA·August 16, 2019

CLP Instrumentation Removal Hook, distributed by DJO Surgical, manufactured by Encore Medical, Austin, TX.

FDA Recall
Terminated ·Product code HWB·November 10, 2010

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

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

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

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

EMPOWR Porous Knee System TIBIAL PUNCH, SMALL, REF 801-05-202, NON STERILE, Qty 1 For use in orthopedic surgery.

FDA Recall
Terminated ·Product code JWH·December 12, 2017

EMPOWR Porous Knee System TIBIAL PUNCH, LARGE, REF 801-05-204, NON STERILE, Qty 1 For use in orthopedic surgery.

FDA Recall
Terminated ·Product code JWH·December 12, 2017

EMPOWR Porous Knee System TIBIAL PUNCH, MEDIUM, REF 801-05-203, NON STERILE, Qty 1 For use in orthopedic surgery.

FDA Recall
Terminated ·Product code JWH·December 12, 2017

djo surgical Screw 6.5 mm, Sz 25mm, low profile. Product is intended for the fixation of the acetabular shell or fracture repair

FDA Recall
Terminated ·Product code HWC·July 16, 2012

Reverse Shoulder Prosthesis System RSP Humeral Socket Shell DJO 9800 Metric Blvd. Austin, TX 78758 STERILE R Model numbers: 508-00-000 and 508-00-008. The Reverse Shoulder Prosthesis (RSP) is indicated for use in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or a previously failed joint replacement with a gross rotator cuff deficient shoulder joint. The patient's joint must be anatomically and structurally suited to receive the selected implant (s), and a functional deltoid muscles in necessary to use the device.

FDA Recall
Terminated ·Product code KWS·April 18, 2011

PRO-DEX Surgical Driver Battery Pack PDBP-001 Series PRO-DEX Battery Pack, Single Pouch - PDBP-001-2 PRO-DEX Battery Pack, 40 Pouches - PDBP-040-2 Product Usage: -The PDBP-001 Battery is a single use (non-rechargeable) sterile lithium ion battery accessory that powers the PDSD Surgical driver. There is only one PDSD Surgical driver currently being produced (PDSD-5000) and the battery only works to power this driver. -The PDSD Series surgical drivers are Pro-Dex Branded surgical fixation drivers meant to drive surgical screws into bone in the CMF region of the body. They are class I exempt (Product codes GEY/GXL) battery powered hand pieces with a fixed collet. The only accessory is the PDBP-001 battery.

FDA Recall
Terminated ·Pro-Dex Inc·Product code GEY·September 25, 2018

Battery Pack KLS-SD-1000 Case (40 ct) Models: KLS-BP-040 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).

FDA Recall
Terminated ·Pro-Dex Inc·Product code MOQ·December 23, 2015