FDA (Devices) recall action 69471

Instrumed International, Inc. recalled 28 products on 2014-12-17

The FDA (Devices) publishes a recall like this one as 28 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 28 pages.

Products: 28
Announced: 2014-12-17
Critical: 0
Units: 2,354

Why these products were recalled

The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–25 of 28

LowFDA (Devices)··2014-12-17
Instrumed Withdraws McKenzie Perforator Drills for Regulatory Compliance
Instrumed International is withdrawing McKenzie Perforator Drills because the company did not market them before September 26, 1976, failing to meet FDA pre-amendment requirements.
Product
McKenzie Perforator Drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Phoenix Instruments, Stealth Surgical, CareFusion, and Boss Instruments brand names.
Category
Distribution
12 states
LowFDA (Devices)··2014-12-17
Instrumed Recalls Traction Tong Replacement Screws for Regulatory Compliance
Instrumed International is withdrawing 17 traction tong replacement screws because they do not meet FDA requirements for pre-amendment devices.
Product
Traction tong replacement screws, non-springloaded are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and are sold under the CareFusion, Boss Instruments, and Stealth Surgical brand names.
Category
Distribution
12 states
LowFDA (Devices)··2014-12-17
Instrumed Recalls Schoitz Weights for Regulatory Compliance Issues
Instrumed International is withdrawing Schoitz weights from the market because the devices do not meet FDA requirements for pre-amendment marketing.
Product
Schoitz weights are manual devices used with Schoitz tonometers and are intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (app
Category
Distribution
12 states
LowFDA (Devices)··2014-12-17
Instrumed Recalls Cloward Spanner Gauges Due to Regulatory Non-Compliance
Instrumed International is withdrawing Cloward Spanner gauges because the company did not market them before 1976, failing to meet FDA requirements for pre-amendment devices.
Product
Cloward Spanner gauges are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareFusion and Boss Instruments brand names.
Category
Distribution
12 states
LowFDA (Devices)··2014-12-17
Instrumed Recalls Zipser Meatus Clamps Due to Regulatory Non-Compliance
Instrumed International is withdrawing 81 Zipser Meatus Clamps because the company did not market the devices prior to 1976, failing to meet FDA requirements for pre-amendment devices.
Product
A zipser clamp is an instrument used to compress reduce blood flow to the penis and reduce pain and is sold under the Medline Industries, Boss Instruments, Millennium Surgical, Medetz Surgical, Surgical Direct, and Surgipro brand names.
Category
Distribution
12 states
LowFDA (Devices)··2014-12-17
Instrumed Withdraws McKenzie Enlarging Burrs Due to Regulatory Non-Compliance
Instrumed International is withdrawing McKenzie enlarging burrs because the company did not market them prior to 1976, failing to meet FDA pre-amendment requirements.
Product
McKenzie enlarging burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareFusion and Boss Instruments brand names.
Category
Distribution
12 states
LowFDA (Devices)··2014-12-17
Instrumed Recalls Hudson Cranial Drill Sets for Regulatory Non-Compliance
Instrumed International is withdrawing five Hudson cranial drill sets because the company failed to meet FDA requirements for marketing pre-amendment devices.
Product
Hudson cranial drill sets (w/ brace and 5 attachments) are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Medfix International, Stealth Surgical, and Boss Instruments brand names.
Category
Distribution
12 states
LowFDA (Devices)··2014-12-17
Instrumed Recalls Endometrial Suction Curettes Due to Regulatory Non-Compliance
Instrumed International is withdrawing 26 endometrial suction curettes because the devices were not marketed before September 26, 1976, and do not meet FDA pre-amendment requirements.
Product
An endometrial suction curette is a device used to remove material from the uterus and from the mucosal lining of the uterus by scraping and vacuum suction. This device is used to obtain tissue for biopsy or for menstrual extraction. This generic type of device may include cathet
Category
Distribution
12 states
LowFDA (Devices)··2014-12-17
Gardner-Wells wrenches withdrawn for pre-amendment regulatory non-compliance
Instrumed International is withdrawing Gardner-Wells wrenches because they were not marketed prior to September 26, 1976, and do not meet FDA pre-amendment requirements.
Product
Gardner-Wells wrenches are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and sold under the CareFusion brand name.
Category
Distribution
12 states
LowFDA (Devices)··2014-12-17
Instrumed Recalls Cushing Perforating Drills for Regulatory Non-Compliance
Instrumed International is withdrawing nine Cushing perforating drills because the company did not market them before September 26, 1976, failing to meet FDA pre-amendment requirements.
Product
Cushing perforating drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Boss Instruments, Symmetry Surgical, Medfix International, Stealth Surgical, and CareFusion brand names.
Category
Distribution
12 states
LowFDA (Devices)··2014-12-17
Instrumed Recalls CVB Distraction Screws Due to Regulatory Non-Compliance
Instrumed International is withdrawing 790 CVB distraction screws because the devices were not marketed before 1976, failing FDA pre-amendment requirements.
Product
CVB distraction screws are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Millennium Surgical, Medfix International, CareFusion, Boss Instruments, Medline Industries, Surgical Direct, and Telef
Category
Distribution
12 states
LowFDA (Devices)··2014-12-17
Instrumed Recalls Titanium Fixation Screws for Regulatory Compliance Issues
Instrumed International is withdrawing 22 springloaded titanium fixation screws from the market because the devices were not marketed prior to 1976 and do not meet FDA pre-amendment requirements.
Product
Titanium fixation screws, springloaded are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and are sold under the Millennium Surgical, Boss Instruments, Stealth Surgical, and CareFusion brand name
Category
Distribution
12 states
LowFDA (Devices)··2014-12-17
Instrumed Recalls Galt Trephines for Regulatory Compliance Issues
Instrumed International is withdrawing Galt trephines because the company did not market them prior to September 26, 1976, failing to meet FDA pre-amendment requirements.
Product
Galt trephines are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareFusion brand name.
Category
Distribution
12 states
ModerateFDA (Devices)··2014-12-17
Instrumed Recalls External Vein Strippers Due to Regulatory Non-Compliance
Instrumed International is withdrawing 479 external vein strippers because the company did not market them before 1976, failing to meet FDA pre-amendment requirements.
Product
An external vein stripper is an extravascular device used to remove a section of a vein sold under the Symmetry Surgical, CareFusion, Boss Instruments, Phoenix Instruments, Autobahn Surgical, Echo Instruments, Millennium Surgical, B.B.M. Surgical Instruments, Stealth Surgical, Me
Category
Distribution
12 states
LowFDA (Devices)··2014-12-17
Instrumed Recalls 23 Schiotz Tonometers for Regulatory Non-Compliance
Instrumed International is withdrawing 23 Schiotz tonometers because the devices do not meet FDA requirements for pre-amendment marketing.
Product
Tonometers are manual devices intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea) and
Category
Distribution
12 states
ModerateFDA (Devices)··2014-12-17
Instrumed Recalls Manual Trephines for Regulatory Compliance
Instrumed International is withdrawing 74 manual trephines from the market because the devices do not meet FDA requirements for pre-amendment marketing.
Product
Manual trephines are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Millennium Surgical, Symmetry Surgical, Medline Industries, CareFusion, Boss Instruments, and Surgical Direct brand names.
Category
Distribution
12 states
LowFDA (Devices)··2014-12-17
Instrumed Recalls Non-Springloaded Traction Tongs for Regulatory Compliance
Instrumed International is withdrawing 67 replacement screw non-springloaded traction tongs because the company did not market them prior to 1976, failing to meet FDA pre-amendment requirements.
Product
Replacement screw non-springloaded traction tongs are skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and sold under the CareFusion, Boss Instruments, Millennium Surgical, Prezio Health, and Stealth Surgical bran
Category
Distribution
12 states
LowFDA (Devices)··2014-12-17
Instrumed Recalls Lock Nuts for Titanium Traction Tongs
Instrumed International is withdrawing 49 lock nuts for titanium traction tongs because the devices were not marketed prior to September 26, 1976, and do not meet FDA pre-amendment requirements.
Product
Lock nuts for titanium traction tongs are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and are sold under the CareFusion, Millennium Surgical, Boss Instruments, and Stealth Surgical brand names
Category
Distribution
12 states
LowFDA (Devices)··2014-12-17
Instrumed Recalls Mogen Circumcision Clamps for Regulatory Non-Compliance
Instrumed International is withdrawing 421 Mogen circumcision clamps because the company did not market these devices prior to September 26, 1976, failing to meet FDA pre-amendment requirements.
Product
A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant sold under the Medline Industries, Boss Instruments, Millennium Surgical, Medetz Surgical, Surgical Direct, Surgipro, Teleflex Medical, Boss Instruments, Symmetry
Category
Distribution
12 states
ModerateFDA (Devices)··2014-12-17
Instrumed Recalls Cushing Burr Instruments for Regulatory Non-Compliance
Instrumed International is withdrawing Cushing burrs because the company failed to meet FDA requirements for marketing pre-amendment devices.
Product
Cushing burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Medfix International and Stealth Surgical brand names.
Category
Distribution
12 states
LowFDA (Devices)··2014-12-17
Instrumed Recalls D'errico Perforator Drills Due to Regulatory Non-Compliance
Instrumed International is withdrawing D'errico perforator drills because they do not meet FDA requirements for pre-amendment devices.
Product
D'errico perforator drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Teleflex Medical, and CareFusion brand names.
Category
Distribution
12 states
LowFDA (Devices)··2014-12-17
Instrumed Recalls Gardner-Wells Traction Tongs for Regulatory Compliance
Instrumed International is withdrawing 190 Gardner-Wells traction tongs because the company did not market them before September 26, 1976, failing to meet FDA pre-amendment requirements.
Product
Gardner-Wells traction tongs are skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and sold under the Millenium Surgical, Echo Instruments, Adler Instrument, Surgical Direct, Stealth Surgical, CareFusion, and Boss I
Category
Distribution
12 states
ModerateFDA (Devices)··2014-12-17
Instrumed Recalls Uterine Tenaculum Hooks for Regulatory Compliance
Instrumed International is withdrawing 26 uterine tenaculum hooks because the company did not market them prior to September 26, 1976, failing to meet FDA pre-amendment requirements.
Product
A uterine tenaculum is a hook-like instrument used to seize and hold the cervix or fundus sold under the CareFusion, Teleflex Medical, Symmetry Surgical brand names. A uterine tenaculum is a hook-like instrument used to seize and hold the cervix or fundus.
Category
Distribution
12 states
LowFDA (Devices)··2014-12-17
Instrumed Recalls Hudson Burrs for Pre-Amendment Regulatory Non-Compliance
Instrumed International is withdrawing 16 Hudson burrs from the market because the company did not market these devices prior to September 26, 1976, and therefore does not meet FDA requirements for Pre-Amendment devices.
Product
Hudson burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Medfix International, CareFusion, Boss Instruments, and Medline Industries brand names.
Category
Distribution
12 states
LowFDA (Devices)··2014-12-17
Instrumed Recalls Surgical Trocars Due to Regulatory Non-Compliance
Instrumed International is withdrawing 11 surgical trocars because they do not meet FDA requirements for pre-amendment devices.
Product
A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula sold under the Symmetry Surgical, CareFusion, and Ambler Surgical brand names.
Category
Distribution
12 states