48 results
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28ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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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
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
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
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 3D Knee (Right) 10mm Tibial Insert, REF: 342-10-708
FDA Recall
Open, Classified
·Product code JWH·May 5, 2022
DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 Left 3D MATRIX COATED REF 243-01-108 DJO surgical EMPOWR KNEE", PRESS FIT BP MINUS, 8L REF 353-03-108 For the treatment of patients who are candidates for knee arthroplasty per the Indication for use.
FDA Recall
Open, Classified
·Product code MBH·November 10, 2023
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 Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106
FDA Recall
Open, Classified
·Product code JWH·August 4, 2023
DJO Surgical: Delta Ceramic Femoral Head, 44 mm + 4.0 mm, REF: 400-03-443
FDA Recall
Open, Classified
·Product code LZO·August 4, 2023
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
RSP Glenoid Baseplate, 30mm P2 Porous Coated REF 508-32-204. DJO Surgical shoulder device.
FDA Recall
Open, Classified
·Product code PHX·September 6, 2023
Turon Shoulder System Instrumentation, Turon Pegged Glenoid Drill Guide, REF 804-25-024, DJO Surgical
FDA Recall
Terminated
·Product code KWS·November 5, 2010
DJO Surgical: Altivate Reverse, Humeral Stem, Small Shell, Size 6 x 108mm, REF: 533-06-108
FDA Recall
Open, Classified
·Product code KWS·August 4, 2023
DJO Surgical: CLP Hip, Stem, Polished Neck, Lateral Offset Implant, Size#3, REF: 426-11-030
FDA Recall
Open, Classified
·Product code KWA·August 4, 2023
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
DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-12-711, Left Sz. 11 12mm, CE0086, Sterile H2O2, UDI: (01)00888912166980
FDA Recall
Open, Classified
·Product code JWH·May 12, 2021
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