BEUDAMED
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    Excia Cemented Hip Stems, Size 12mm, Part Number: NJ312K, Aesculap Implant Systems, Inc., Center Valley, PA 18034

    FDA Recall
    Terminated ·Aesculap Implant Systems·Product code LWJ·October 10, 2007

    Products are various dental surgical drills packed in a sealed tray and labeled as sterile. The tray is labled as follows: 3i Implant Innovations, Inc., 4555 Riverside Drive, Palm Beach 33410 USA 561-776-6700 DT220 2.3mm (D) x 20.0 mm (L) STERILE.

    FDA Recall
    Terminated ·Implant Innovations, Inc.·Product code DZI·December 2, 2003

    Products are various dental surgical drills packed in a sealed tray and labeled as sterile. The tray is labled as follows: 3i Implant Innovations, Inc., 4555 Riverside Drive, Palm Beach 33410 USA 561-776-6700 DT 310 LOT 3.0 mm (D) X 10.0 mm (L) STERILE

    FDA Recall
    Terminated ·Implant Innovations, Inc.·Product code DZI·December 2, 2003

    Excia Cemented Hip Stems, Size 17mm, Part Number : NJ317K, Aesculap Implant Systems, Inc., Center Valley, PA 18034

    FDA Recall
    Terminated ·Aesculap Implant Systems·Product code LWJ·October 10, 2007

    IDEAL IMPLANT Structured Breast Implant, saline breast implant, in the following sizes: 210cc, 240cc, 270cc, 300cc, 335cc, 370cc, 405cc, 440cc, 475cc, 515cc, 555cc, 595cc, 635cc, and 675cc.

    FDA Recall
    Terminated ·Ideal Implant Incorporated·Product code FWM·March 18, 2019

    FlareHawk Interbody Fusion System (previously XCage Interbody Fusion System) Instructions for Use (IFU's) only. Product Usage: Indicated for spinal intervertebral body fusion with autogenous bone graft in skeletally mature individuals with degenerative disc disease.

    FDA Recall
    Terminated ·Integrity Implants Inc.·Product code MAX·February 27, 2018

    Products are various dental surgical drills packed in a sealed tray and labeled as sterile. The tray is labled as follows: 3i Implant Innovations, Inc., 4555 Riverside Drive, Palm Beach 33410 USA 561-776-6700 DDK315 LOT Disposable Drill Kit with DT315 STERILE

    FDA Recall
    Terminated ·Implant Innovations, Inc.·Product code DZI·December 2, 2003

    Excia Cemented Hip Stems, Size 14mm, Part Number : NJ314K, Aesculap Implant Systems, Inc., Center Valley, PA 18034

    FDA Recall
    Terminated ·Aesculap Implant Systems·Product code LWJ·October 10, 2007

    Excia Cemented Hip Stems ,Size 18mm, Part Number NJ318K, Aesculap Implant Systems, Inc., Center Valley, PA 18034

    FDA Recall
    Terminated ·Aesculap Implant Systems·Product code LWJ·October 10, 2007

    Excia Cemented Hip Stems, Size 13mm, Part Number : NJ313K, Aesculap Implant Systems, Inc., Center Valley, PA 18034

    FDA Recall
    Terminated ·Aesculap Implant Systems·Product code LWJ·October 10, 2007

    Product is a drill used in dental surgery labeled in part: OFDR8 OsseoFix Drill 8mm Length 3i Implant Innovations, Inc. 4555 Riverside drive, Palm Beach Gardens, FL 33410 Non Sterile Contents must be sterilized prior to use. RX only.

    FDA Recall
    Terminated ·Implant Innovations, Inc.·Product code DZE·May 9, 2003

    LineSider Spinal System pedicle screws, 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Model Number LS-N6SG6545. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sold as non-sterile and shipped in protective sterilization trays. Screws can also be shipped individually, as tray replenishments. Used in spinal fixation surgery.

    FDA Recall
    Terminated ·Integrity Implants Inc.·Product code NKB·August 3, 2022

    LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Cannulated. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sold as non-sterile and shipped in protective sterilization trays. Screws can also be shipped individually, as tray replenishments. Labeled as the following sizes: a. 5.5mm x 35mm; b. 5.5mm x 40mm; c. 5.5mm x 45mm; d. 5.5mm x 50mm; e. 5.5mm x 55mm; f. 6.5mm x 35mm; g. 6.5mm x 40mm; h. 6.5mm x 45mm; i. 6.5mm x 50mm; j. 6.5mm x 55mm; k. 6.5mm x 60mm; l. 7.5mm x 35mm; m. 7.5mm x 40mm; n. 7.5mm x 45mm; o. 7.5mm x 50mm; p. 7.5mm x 55mm; q. 7.5mm x 60mm; r. 8.5mm x 35mm; s. 8.5mm x 40mm; t. 8.5mm x 45mm; u. 8.5mm x 50mm; v.8.5mm x 55mm; w. 8.5mm x 60mm; Used in spinal fixation surgery.

    FDA Recall
    Terminated ·Integrity Implants Inc.·Product code NKB·January 27, 2022

    Products are surgical drills packaged separately or included in a surgical kit so two products will be listed. The second product is the 8mm drill included in a kit and It is labeled as OFKIT2 OsseoFix System Complete (Kit)3i Implant Innovations, Inc. 4555 Riverside drive, Palm Beach Gardens, FL 33410 Non Sterile Contents must be sterilized prior to use. RX only.

    FDA Recall
    Terminated ·Implant Innovations, Inc.·Product code DZE·May 9, 2003

    EP Healing Abutment- An abutment device is a premanufactured prosthetic component directly connected to the endosseous dental implant.

    FDA Recall
    Terminated ·Implant Innovations, Inc.·Product code DZE·October 4, 2004

    Excia Cemented Hip Stems, Size 16mm, Part Number NJ316K, Aesculap Implant Systems, Inc., Center Valley, PA 18034

    FDA Recall
    Terminated ·Aesculap Implant Systems·Product code LWJ·October 10, 2007

    Tri-Nex Healing Abutment, 0.50 mm x 5 mm height, Catalog No. HA-L-50-5. The NSI Implant System is intended to be implanted in the upper and lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.

    FDA Recall
    Terminated ·Southern Implants, Inc·Product code NHA·September 13, 2013

    LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sold as non-sterile and shipped in protective sterilization trays. Screws can also be shipped individually, as tray replenishments. Labeled as the following sizes: a. 5.5mm x 35mm; b. 5.5mm x 40mm; c. 5.5mm x 45mm; d. 5.5mm x 50mm; e. 5.5mm x 55mm; f. 6.5mm x 35mm; g. 6.5mm x 40mm; h. 6.5mm x 45mm; i. 6.5mm x 50mm; j. 6.5mm x 55mm; k. 6.5mm x 60mm; l. 7.5mm x 35mm; m. 7.5mm x 40mm; n. 7.5mm x 50mm; o. 7.5mm x 55mm; p. 7.5mm x 60mm; q. 8.5mm x 35mm; r. 8.5mm x 40mm; s. 8.5mm x 45mm; t. 8.5mm x 50mm; u.8.5mm x 55mm; v. 8.5mm x 60mm; Used in spinal fixation surgery.

    FDA Recall
    Terminated ·Integrity Implants Inc.·Product code NKB·January 27, 2022

    LineSider Spinal System 5.5/6.0mm, Non-mod MIS 7.1mm - Dual Lead, Cannulated. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sold as non-sterile and shipped in protective sterilization trays. Screws can also be shipped individually, as tray replenishments. Labeled as the following sizes: a. 5.5mm x 35mm; b. 5.5mm x 40mm; c. 5.5mm x 45mm; d. 5.5mm x 50mm; e. 6.5mm x 35mm; f. 6.5mm x 40mm; g. 6.5mm x 45mm; h. 6.5mm x 50mm; i. 6.5mm x 55mm; j. 7.5mm x 35mm; k. 7.5mm x 40mm; l. 7.5mm x 45mm; m. 7.5mm x 50mm; n. 7.5mm x 55mm; o. 8.5mm x 35mm; p. 8.5mm x 40mm; q. 8.5mm x 45mm; r. 8.5mm x 50mm; s.8.5mm x 55mm; t. 9.5mm x 35mm; u. 9.5mm x 40mm; v. 9.5mm x 45mm; w. 9.5mm x 50mm; x. 9.5mm x 55mm; Used in spinal fixation surgery.

    FDA Recall
    Terminated ·Integrity Implants Inc.·Product code NKB·January 27, 2022

    Columbus Tibia Plateau (component of the Columbus REVISION Knee System) Product Usage - The Columbus Revision Knee System is indicated for use in reconstruction of the diseased knee joint caused by osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, the need to revise failed arthroplastics or osteotomies where pain, deformity or dysfunction persist, and for patients suffering from correctable valgus or varus deformity and moderate flexion contracture

    FDA Recall
    Terminated ·Aesculap Implant Systems·Product code JWH·February 21, 2012