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Medical Devices Recalls

Medical equipment, implants, and diagnostic devices

38,779 Total Recalls

Manual bunnell cranial drills are bone cutting and drilling instruments that are used without a power source on a patient's skull sold under the Boss Instruments brand name.

Instrumed International

Class I - Dangerous

The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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

Sep 8, 2014 Surgical Instruments Nationwide View Details →

Soft Contact Lens

Cooper Vision Caribbean

Class I - Dangerous

Portions of the lots may contain units with an incorrect lens axis condition.

Oct 28, 2014 Other Medical Devices Nationwide View Details →

1488 HD 3-Chip Inline Camera; Model Number 1488-710-105 - HD 3-Chip Inline Camera, C-Mount; Product Usage: High definition camera to view endoscopic surgical sites on video monitors and capture still and video images of endoscopic surgical applications. Indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy and plastic surgery wherever a laparoscope/endoscope/arthroscope is indicated for use.

Stryker Endoscopy

Class I - Dangerous

In certain operating room environments, a colored screen image occurs with the 1488 Cameras that were manufactured during a specific time period

Mar 5, 2013 Implants & Prosthetics Nationwide View Details →

Align Radial Stems, Prosthesis, Elbow, Hemi Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with: Joint destruction and/or subluxation and resistance to conservative treatment. Intended use is also for primary replacement after fracture of the radial head and symptomatic sequelae after radial head resection.

Skeletal Dynamics

Class I - Dangerous

Report received where the Align Radial Stem fractured.

Oct 16, 2014 Implants & Prosthetics Nationwide View Details →

Zimmer Title 2 Bone Screw Remover Instrument, Part Number ET1093-01 Rx Only, Non-Sterile. The Screw Remover is a component of the Endius TITLE 2 Polyaxial Spinal System, used for posterior lumbar fusion procedures.

Zimmer

Class I - Dangerous

Possibility of the weld to the quick-connect breaking when force is applied to the handle for pedicle screw removal. A broken weld could lead to the use of an alternate method of screw removal, which could delay surgery up to 30 minutes.

Aug 26, 2013 Surgical Instruments Nationwide View Details →

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.

Instrumed International

Class I - Dangerous

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.

Sep 8, 2014 Other Medical Devices Nationwide View Details →

Micro Introducer Kit, 5F Micro Introducer Kit, Ref No. M4005 Product Usage: These introducers are used for the percutaneous introduction of therapeutic devices, such as PICCS. The PFM CT PICC catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, and power injection of contrast media.

Pfm Medical

Class I - Dangerous

PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.

Oct 20, 2014 Surgical Instruments Nationwide View Details →

Distal Access Catheter: Model Numbers: 90121, 90130, 90131, 90160. The Distal Access Catheter is intended for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vascular systems.

Concentric Medical

Class I - Dangerous

Distal Access Catheters were shipped to US customers with the Directions for Use that included instructions for aspiration. This version of the DFU is only approved outside of the US.

Sep 26, 2013 Surgical Instruments View Details →

Trevo Pro 4 Stent Retriever, Model number 80021; U.S. Indications for use: The Trevo Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

Concentric Medical

Class I - Dangerous

Product shipped to US customers had non U.S. Instruction for use with indication for Use that were not aligned with U.S. indications.

Nov 13, 2013 Implants & Prosthetics View Details →

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.

Instrumed International

Class I - Dangerous

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.

Sep 8, 2014 Surgical Instruments Nationwide View Details →

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.

Instrumed International

Class I - Dangerous

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.

Sep 8, 2014 Surgical Instruments Nationwide View Details →