🍔 Food 💊 Drugs 🏥 Medical Devices
NeuraWrap Nerve Protector NeuraWrap Nerve Protector is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue. Class II

Reason: Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

Integra LifeSciences Corporation 20130328 Terminated
Distributed: Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.
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DuraGen XS Dural Regeneration Matrix DuraGen XS Dural Regenerative Matrix is an absorbable implant for repair of dural defects. DuraGen XS is an easy to handle, soft, white, pliable, non-friable, porous collagen matrix. DuraGen XS is supplied sterile, non-pyrogenic, for single use in double peel packages in a variety of sizes. Class II

Reason: Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

Integra LifeSciences Corporation 20130328 Terminated
Distributed: Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.
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DuraGen Plus Dural Regeneration Matrix DuraGen Plus Adhesion Barrier Matrix is an absorbable implant for repair and restoration of dural defects and as an adhesion barrier for the reduction of peridural fibrosis. DuraGen Plus matrix is an easy to handle, soft, white pliable, non-friable, porous, collagen matrix. DuraGen Plus matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes. Class II

Reason: Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

Integra LifeSciences Corporation 20130328 Terminated
Distributed: Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.
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Suturable DuraGen Dural Regenerative Matrix Suturable DuraGen Dural Regenerative Matrix is an absorbable implant for repair of dural defects. Suturable DuraGen is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix with a mechanically strengthened collagen component. Suturable DuraGen is supplied sterile, non-pyrogenic, for single use in double peel packages in a variety of sizes. Suturable DuraGen may be applied using either on-lay or suturing techniques depending on clinical need and surgeon preference. Class II

Reason: Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

Integra LifeSciences Corporation 20130328 Terminated
Distributed: Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.
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Dural Graft Matrix DuraGen¿ Dural Graft Matrix is an absorbable implant for repair of dural defects. DuraGen matrix is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix. DuraGen matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes.. Class II

Reason: Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

Integra LifeSciences Corporation 20130328 Terminated
Distributed: Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.
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Insight Instruments MIS ( Multi-Port Illumination System) Illuminated pilot tubes work like a ceiling light while simultaneously protecting the entry sites. Illumination automatically follows the movement of the two surgical instruments inserted into the M.I.S. cannulas. The large distance of more than 16mm between cannula ends and posterior pole guarantees sufficient light in the working area and a large observation field especially when used in conjunction with modern wide field panoramic observation systems. Class II

Reason: Insight Instruments, Inc., Stuart, FL is recalling M.I.S. (Multi-Port Illumination System), Ophthalmic Cannula due to a misclassification of the medical device.

Insight Instruments, Inc. 20130315 Terminated
Distributed: US Distribution IN and IL
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AMS 800¿ Urinary Control System. The AMS 800¿ Urinary Control System is used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery. The AMS 800¿ Urinary Control System is an implantable, fluid filled, solid silicone elastomer device used to treat stress urinary incontinence. It is designed to restore the natural process of urinary control. The device simulates normal sphincter function by opening and closing the urethra at the control of the patient. The AMS 800 system consists of three inter connected components: a cuff, a pump, and a pressure-regulating balloon. The three components are connected with kink-resistant tubing. The AMS 800 can be implanted at either the bulbous urethra or the bladder neck. Class II

Reason: American Medical Systems, Inc. is initiating a recall on two components of the AMS 800¿ Urinary Control System, Control Pump & Pressure-Regulating Balloon. These products were released despite not meeting all final product release criteria.

American Medical Systems, Inc. 20130301 Terminated
Distributed: Worldwide Distribution -- Nationwide Distribution including the states of AL, AZ, AR, CA, CO, CT, DE, FL, GA, IL, IN, IA, KS, KY LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NH, NJ, NM, NY,NC, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VT, VA, WA and WI., and the countries of AUSTRIA, AUSTRALIA, CANADA, BELGIUM, SWITZERLAND, CZECH REPUBLIC, GERMANY, DENMARK, ESTONIA, SPAIN, FINLAND, FRANCE, GREAT BRITAIN, IRELAND, ITALY, LEBANON, NETHERLANDS, NORWAY, SWEDEN, TURKEY, ARGENTINA, BRAZIL, IVORY COST, COLOMBIA, ECUADOR, INDIA, JAPAN, MEXICO, NEW ZEALAND, PANAMA and VENEZUELA.
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AMS 800¿ Urinary Control System. The AMS 800¿ Urinary Control System is used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery. The AMS 800¿ Urinary Control System is an implantable, fluid filled, solid silicone elastomer device used to treat stress urinary incontinence. It is designed to restore the natural process of urinary control. The device simulates normal sphincter function by opening and closing the urethra at the control of the patient. The AMS 800 system consists of three inter connected components: a cuff, a pump, and a pressure-regulating balloon. The three components are connected with kink-resistant tubing. The AMS 800 can be implanted at either the bulbous urethra or the bladder neck. Class II

Reason: American Medical Systems, Inc. is initiating a recall on two components of the AMS 800¿ Urinary Control System, Control Pump & Pressure-Regulating Balloon. These products were released despite not meeting all final product release criteria.

American Medical Systems, Inc. 20130301 Terminated
Distributed: Worldwide Distribution -- Nationwide Distribution including the states of AL, AZ, AR, CA, CO, CT, DE, FL, GA, IL, IN, IA, KS, KY LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NH, NJ, NM, NY,NC, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VT, VA, WA and WI., and the countries of AUSTRIA, AUSTRALIA, CANADA, BELGIUM, SWITZERLAND, CZECH REPUBLIC, GERMANY, DENMARK, ESTONIA, SPAIN, FINLAND, FRANCE, GREAT BRITAIN, IRELAND, ITALY, LEBANON, NETHERLANDS, NORWAY, SWEDEN, TURKEY, ARGENTINA, BRAZIL, IVORY COST, COLOMBIA, ECUADOR, INDIA, JAPAN, MEXICO, NEW ZEALAND, PANAMA and VENEZUELA.
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Zilver PTX Drug-Eluting Peripheral Stent, - 7 mm X 80mm; 125 cm, Rx, Sterile Product Usage: The Zilver PTX Drug -Eluting Peripheral Stent is a self expanding, small metal, mesh tube (stent) with the outer surface coated with the drug Paclitaxel that can be Implanted in an artery in the thigh (femoropopliteal artery). The Paclitaxel coating helps prevent the artery from narrowing again (restenosis). The Zilver; PTX stent acts as a scaffold to: Hold open a narrowed artery in the thigh (femoropopliteal artery) caused by PAD. Improve blood flow to the extremity. Class I

Reason: Cook Medical has received a small number of complaints related to the delivery system for the Zilver PTX Drug-Eluting Peripheral Stent involving fractures of the delivery system inner catheter after stent deployment, and separation of the inner catheter tip section (13 complaints with an occurrence rate of 0.043%) Two adverse events, including one death, occurred in cases where a tip separation

Cook, Inc. 20130418 Terminated
Distributed: Worldwide Distribution - USA Nationwide; in the countries of Japan, Europe, Brazil, and Australia
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Zilver¿ PTX¿ Drug-Eluting Peripheral Stent - 6 mm X 80mm; 125 cm, Rx, Sterile Product Usage: The Zilver PTX Drug -Eluting Peripheral Stent is a self expanding, small metal, mesh tube (stent) with the outer surface coated with the drug Paclitaxel that can be Implanted in an artery in the thigh (femoropopliteal artery). The Paclitaxel coating helps Preven the artery from narrowing again (restenosis). The Zilver; PTX stent acts as a scaffold to:  Hold open a narrowed artery in the thigh (femoropopliteal artery) caused by PAD .  improve blood flow to the extremity. Class I

Reason: Cook Medical has received a small number of complaints related to the delivery system for the Zilver PTX Drug-Eluting Peripheral Stent involving fractures of the delivery system inner catheter after stent deployment, and separation of the inner catheter tip section (13 complaints with an occurrence rate of 0.043%) Two adverse events, including one death, occurred in cases where a tip separation

Cook, Inc. 20130418 Terminated
Distributed: Worldwide Distribution - USA Nationwide; in the countries of Japan, Europe, Brazil, and Australia
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