BEUDAMED
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    Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Inserts: N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS INS TIB SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code JWH·February 25, 2014

    Kii Shielded Bladed trocars (CTB14), Kii Low profile trocars (CTB23), and Kii 5x55mm Optical Z-Thread Dual Pack (CTR14) trocars.

    FDA Recall
    Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code GCJ·May 4, 2017

    Natural-Knee N-K II DOMED ALL-POLY PAT, SZ0 N-K II DOMED ALL-POLY PAT, SZ1

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code JWH·February 25, 2014

    Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.

    FDA Recall
    Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code GCJ·June 25, 2008

    Applied Medical 15x100mm Kii Optical Access System, Non-Threaded 6/Box, Model Number: C0R36, Labeled Sterile. Disposable single-use devices indicated for use in general, abdominal, gynecological and thoracic minimally invasive surgeries. Endoscopic instruments for surgery.

    FDA Recall
    Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa·Product code GCJ·June 4, 2009

    Applied Medical 15x100 mm Kii Optical Access Systems, Non-Threaded 6/Box, Model C0R38 Product Usage: Applied Medical's C0R36, C0R37, C0R38, and C0R39 trocars are diposable single-use devices indicated for use in general, abdominal, gynecological and thoraic minimally invasive surgeries. Trocars establish a path of entry through tissue planes and into internal spaces for purposes of inserting endoscopic instruments that are used to perform surgery on internal organs.

    FDA Recall
    Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa·Product code GCJ·December 18, 2009

    Applied Medical 15x100 mm Kii Optical Access Systems, Non-Threaded 6/Box, Model C0R39 Product Usage: Applied Medical's C0R36, C0R37, C0R38, and C0R39 trocars are diposable single-use devices indicated for use in general, abdominal, gynecological and thoraic minimally invasive surgeries. Trocars establish a path of entry through tissue planes and into internal spaces for purposes of inserting endoscopic instruments that are used to perform surgery on internal organs.

    FDA Recall
    Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa·Product code GCJ·December 18, 2009

    Applied Medical 15x100 mm Kii Optical Access Systems, Non-Threaded 6/Box, Model C0R36 Product Usage: Applied Medical's C0R36, C0R37, C0R38, and C0R39 trocars are diposable single-use devices indicated for use in general, abdominal, gynecological and thoraic minimally invasive surgeries. Trocars establish a path of entry through tissue planes and into internal spaces for purposes of inserting endoscopic instruments that are used to perform surgery on internal organs.

    FDA Recall
    Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa·Product code GCJ·December 18, 2009

    Applied Medical 15x100 mm Kii Optical Access Systems, Non-Threaded 6/Box, Model C0R37 Product Usage: Applied Medical's C0R36, C0R37, C0R38, and C0R39 trocars are diposable single-use devices indicated for use in general, abdominal, gynecological and thoraic minimally invasive surgeries. Trocars establish a path of entry through tissue planes and into internal spaces for purposes of inserting endoscopic instruments that are used to perform surgery on internal organs.

    FDA Recall
    Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa·Product code GCJ·December 18, 2009

    Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23

    FDA Recall
    Open, Classified ·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code GCJ·December 11, 2025

    Kii Fios First Entry, 5 X 75 mm, RX only, REF CFF05 Qty: 6, Sterile R, Lot: 1330981, Exp: July 15, 2021, Applied Medical Resource Corp. Product Usage: Kii Fios first entry is indicated for use in general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments, and as a means of insufflating the peritoneum prior to laparoscopic procedures.

    FDA Recall
    Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code GCJ·January 28, 2019

    NKII CSTI Porous Femoral NKII NP Femoral prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer variou sizes Product Usage "" The Natural-Knee II System with Cancellous-Structured Titanium (CSTi) Porous Coating is indicated for uncemented or cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD). " The Natural-Knee II primary components without CSTi Porous Coating, all posterior stabilized and revision components, the N-K II Constrained Knee System, the modular cemented tibial baseplate, and the revision stem and revision fluted stem are indicated for cemented use only in skeletally mature individuals with conditions of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD), correctable valgus-varus deformity and moderate flexion contracture, or failed previous surgery where pain, deformity or dysfunction persists. When the primary or N-K II Constrained Knee System components are used, the medial and collateral ligaments must be intact. " The Natural-Knee II Durasul polyethylene components are indicated for patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory degenerative joint disease (IJD), e.g., rheumatoid arthritis; correctable valgus-varus deformity and moderate flexion contracture; those patients with failed previous surgery where pain, deformity, or dysfunction persists; and revision of previously failed knee arthroplasty. These devices are intended for cemented use only in the United States."

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code JWH·January 11, 2016

    Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.

    FDA Recall
    Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code GCJ·June 25, 2008

    Medical Device Exchange - KII FIOS FIRST ENTRY 5X100MM; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number CFF03 EXP (repackager), Applied Medical (OEM) Laparoscope, General & Plastic Surgery.

    FDA Recall
    Terminated ·EXP Pharmaceutical Services Corp·Product code GCJ·February 11, 2015

    Laparoscope, general; plastic surgery Used for general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments.

    FDA Recall
    Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa·Product code CGJ·November 5, 2012

    Zimmer Natural-Knee II System Modular Cemented Tibial Baseplate, Right, Size 3, For cemented use only, sterile, Zimmer, Warsaw, IN; REF 6420-01-230. The modular cemented tibial baseplate is indicated for cemented use only in skeletally mature individuals with conditions of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD), correctable valgus-varus deformity and moderate flexion contracture, or failed previous surgery where pain, deformity or dysfunction persists. When the primary or N-K II Constrained Knee System components are used, the medial and collateral ligaments must be intact. These are single use implantable devices sold sterile.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code JWH·November 25, 2008

    Natural-Knee II Durasul All-Poly Patella, Size 1, 7mm The Zimmer Natural-Knee II Durasul Patella product is a semi-constrained total knee prosthesis consisting of four anatomically designed components: the femoral, tibial, articular surface, and patellar prosthesis. The all-polyethylene patella is made from Durasul Highly Crosslinked Ultra High Molecular Weight Polyethylene. The N-K II Durasul polyethylene patella components are indicated for patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory degenerative joint disease (IJD), e.g., rheumatoid arthritis; correctable valgus-varus deformity and moderate flexion contracture; those patients with failed previous surgery where pain, deformity, or dysfunction persists; and revision of previously failed knee arthroplasty.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code JWH·December 21, 2011

    Natural-Knee II Durasul All-Poly Patella, Size 3, 10mm The Zimmer Natural-Knee II Durasul Patella product is a semi-constrained total knee prosthesis consisting of four anatomically designed components: the femoral, tibial, articular surface, and patellar prosthesis. The all-polyethylene patella is made from Durasul Highly Crosslinked Ultra High Molecular Weight Polyethylene. The N-K II Durasul polyethylene patella components are indicated for patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory degenerative joint disease (IJD), e.g., rheumatoid arthritis; correctable valgus-varus deformity and moderate flexion contracture; those patients with failed previous surgery where pain, deformity, or dysfunction persists; and revision of previously failed knee arthroplasty.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code JWH·December 21, 2011

    Natural-Knee II Durasul All-Poly Patella, Size 3, 7mm The Zimmer Natural-Knee II Durasul Patella product is a semi-constrained total knee prosthesis consisting of four anatomically designed components: the femoral, tibial, articular surface, and patellar prosthesis. The all-polyethylene patella is made from Durasul Highly Crosslinked Ultra High Molecular Weight Polyethylene. The N-K II Durasul polyethylene patella components are indicated for patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory degenerative joint disease (IJD), e.g., rheumatoid arthritis; correctable valgus-varus deformity and moderate flexion contracture; those patients with failed previous surgery where pain, deformity, or dysfunction persists; and revision of previously failed knee arthroplasty.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code JWH·December 21, 2011

    Natural-Knee II Durasul All-Poly Patella, Size 1, 10mm The Zimmer Natural-Knee II Durasul Patella product is a semi-constrained total knee prosthesis consisting of four anatomically designed components: the femoral, tibial, articular surface, and patellar prosthesis. The all-polyethylene patella is made from Durasul Highly Crosslinked Ultra High Molecular Weight Polyethylene. The N-K II Durasul polyethylene patella components are indicated for patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory degenerative joint disease (IJD), e.g., rheumatoid arthritis; correctable valgus-varus deformity and moderate flexion contracture; those patients with failed previous surgery where pain, deformity, or dysfunction persists; and revision of previously failed knee arthroplasty.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code JWH·December 21, 2011