🍔 Food 💊 Drugs 🏥 Medical Devices
BIORAPTOR 2.9 mm Suture Anchor, pack of 1 ULTRABRAID Suture: 72200689 Biodegradable suture anchor Class II

Reason: Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.

Smith & Nephew, Inc. Endoscopy Division 20130806 Terminated
Distributed: Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.
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BIORAPTOR 2.9 mm Suture Anchor Straight, pack of 2 ULTRABRAID Suture; Part Number: 72200690 Biodegradable suture anchor Class II

Reason: Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.

Smith & Nephew, Inc. Endoscopy Division 20130806 Terminated
Distributed: Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.
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BIORAPTOR 2.9 mm Suture Anchor with DURABRAID" Suture; Part Number: 72200783 Biodegradable suture anchor Class II

Reason: Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.

Smith & Nephew, Inc. Endoscopy Division 20130806 Terminated
Distributed: Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.
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BIORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture; Part Number: 72200774 Biodegradable suture anchor Class II

Reason: Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.

Smith & Nephew, Inc. Endoscopy Division 20130806 Terminated
Distributed: Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.
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BIORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture; Part Number: 72200775 Biodegradable suture anchor Class II

Reason: Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.

Smith & Nephew, Inc. Endoscopy Division 20130806 Terminated
Distributed: Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.
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Cypher MIS Screw System, Biomet Spine Parsippany, NJ 07054. The Cypher MIS Screw System is a non-cervical spinal fixation device. 1)Screw Tower - REF 14-501660 2) Rod Reduce - REF 14-501661 3) Counter Torque - REF 14-501662 Class II

Reason: Several complaints were reported to exhibit screw head splay in the Cypher MIS Screw System.

Ebi, Llc 20130813 Terminated
Distributed: Nationwide Distribution (US), including the states of IN, MD, MS, NC, OH, PA, SC, and TX.
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Responder 5 is a nurse call communication system that connects patients with staff in a hospital. The nurse call system also connects team members and departments from radiology, physical therapy, transport, environmental services and more. Responder 5 is used in hospitals and long term patient care facilities to allow for remote communications between patients and patient monitoring devices and healthcare providers Class II

Reason: A counterfeited electronic component was identified in the products affected. The component, a data transceiver (transmitter/receiver), is associated with the intercommunication of these devices in the Responder 5 system across the L-Net data path. Failure of a data transceiver results in the loss of nurse call functionality in the associated room, and may disrupt communications on the L-Net run

Rauland-Borg Corp 20130510 Terminated
Distributed: Worldwide distribution - US: (nationwide) including the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MA, MI, MN, MO, NC, NE, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI and WV., and the countries of : Australia, Canada, Columbia, Lebanon, Mexico and Saudi Arabia.
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Zeppessis' reprocessed single-use manifolds (filters) for the Stryker Neptune 1 and Neptune 2 Waste Management Systems: The Neptune Waste management system is intended to be used in the Operating Room, Surgical Centers and Doctor's Offices to collect and dispose of surgical fluid waste as well as collect smoke generated from electrocautory or laser devices. ***The single-port manifold for the Stryker Neptune 1 (part # 700-015-000) can be used with the: Neptune 1 Gold Rover or the Neptune Bronze Rover as an accessory to Class 2 Air-handling apparatus for a surgical operating room (Sec. 878.5070); or with the Neptune 1 Silver Rover as an accessory to Class 2 Powered suction pump. ***four-port manifold for the Stryker Neptune 1 (part # 700-020-000) can be used with the: Neptune 1 Gold Rover or the Neptune Bronze Rover as an accessory to Class 2 Air-handling apparatus for a surgical operating room (Sec. 878.5070); or with the Neptune 1 Silver Rover as an accessory to Class 2 Powered suction pump. ***single-port manifold for the Stryker Neptune 2 (part # 702-025-000) can be used with the Neptune 2 Rover Ultra as an accessory to Class 2 Powered suction pump. ***four-port manifold for the Stryker Neptune 2 (part # 702-020-000) can be used with the Neptune 2 Rover Ultra as an accessory to Class 2 Powered suction pump. Class II

Reason: Zeppessis' reprocessed single-use manifolds (filters) for the Stryker Neptune 1 and Neptune 2 Waste Management Systems are recalled due to lacking 510K and and without a validated cleaning protocol for reprocessing the used manifolds.

Zeppessis Reprocessing, LLC 20130816 Terminated
Distributed: Distributed in the states of California, Idaho, Oregon, and Washington.
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Device Name: Terino Square Chin-Style II-Medium; Catalog Number: TSCII-M. To augment or reconstruct underdeveloped or traumatized mandibular region. Class II

Reason: Implantech initiated a voluntary recall of certain lots of Terino Square Chin-Style II-Medicum (Lot # 848488 and 850156), after determining that the devices from the lot numbers do not conform to the dimensional requirements for the TSCII-M.

Implantech Associates Inc 20130830 Terminated
Distributed: Worldwide distribution: US (nationwide) including states of NY, KY, and CO, and the country of Israel.
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Brilliance CT 6, M/N 728256; Brilliance CT 16 M/N 728246; Brilliance CT 40, M/N 728235 & Brilliance CT 64 M/N 728231, Philips Healthcare, Cleveland, OH 44143. Intended to produce cross-sectional images of the body by computer reconstruction. Class II

Reason: The patient support may move in an unintended manner if the footswitch cover impinges on the footswitch.

Philips Medical Systems (Cleveland) Inc 20130705 Terminated
Distributed: Worldwide Distribution-USA (nationwide) including DC and the states of AL, AR, AZ, CA, CO, DE, FL, GA, IN, KY, MA, MD, MI, MN, MS, NC, NM, NV, NY, OH, OK, PA, SC, TN, TX, VT, WI & WV, and the countries of Australia, Austria, Bosnia & Herzegovina, Chile, China, Croatia, Denmark, Equatorial Guinea, France, Germany, Greenland, Iceland, Indonesia, Israel, Japan, Kazakhstan, Netherlands, Nigeria, Norway, Poland, Romania, South Africa, South Korea, Sweden, Switzerland, Taiwan, United Arab Emirates, United Kingdom & Vietnam.
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