The firm inventoried and distributed 0.9% Sodium Chloride Saline bags as 0.45% Sodium Chloride Saline bags for use with the VITEK 2 system.
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Surgical Instruments
🏥 Medical Devices • 6,839 recalls
The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Complaint received from sales representative that the drill guide tubes would not screw into replenishment instrument. Upon investigation, it has been determined that the device was not manufactured to design specifications and will not function as intended.
The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Class I - Dangerous
Zimmer is conducting a voluntary removal of some Zimmer A.T.S. 3000 tourniquets after receiving complaints of both out-of-box failures and failures during surgical procedures on some of the affected units. During failure the unit will alarm, lock into a non-operational mode, and the display screen will go blank. Based on investigation, this problem appears to be due to a counterfeit chip on the
"***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-2840***" Ophthalmic surgery
Surgical Specialties Puerto Rico Inc.
Class I - Dangerous
Potential for bent tips.
"***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-3240***" Ophthalmic surgery
Surgical Specialties Puerto Rico Inc.
Class I - Dangerous
Potential for bent tips.
Class I - Dangerous
Package seam of some units may not remain properly sealed to ensure the contents might not be sterile as labeled.
"***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-3040***" Ophthalmic surgery
Surgical Specialties Puerto Rico Inc.
Class I - Dangerous
Potential for bent tips.
Class I - Dangerous
Package seam of some units may not remain properly sealed to ensure the contents might not be sterile as labeled.
The recall was initiated because Alphatec Spine confirmed that the TI Standard Polyaxial Screw Assembly was laser marked with the incorrect length of 45 MM.
A complaint received from sales representative that a replenishment instrument was too short. Upon investigation, it has been determined that the device was not manufactured to design specifications and will not function as intended.
"***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-2740***" Ophthalmic surgery
Surgical Specialties Puerto Rico Inc.
Class I - Dangerous
Potential for bent tips.
The firm initiated the recall because the stainless steel guide-wire of the Illico MIS Fixation System did not completely fit/pass through the tip of certain Illico Ti Cannulated Polyaxial Screws, therefore rendering such screws nonfunctional.
Aviator drill bits are 10 mm longer than the Reflex Hybrid drill bits and are not interchangeable which could lead to over-drilling by as much as 10 mm.
Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants.
Class I - Dangerous
Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the wires contain insufficient lubricity which causes them to get stuck in the housing and become nonfunctional.