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Other Medical Devices

ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 15¿

Globus Medical

Class I - Dangerous

Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.

Jul 22, 2020 Other Medical Devices View Details →

Smart Stapes Protheses Piston 0.6mm X 4.25 mm- Partial Ossicular Replacement Catalog Number: 70143662

Olympus Corporation of the Americas

Class I - Dangerous

Mislabeled outer carton: packaged with the outer carton label stating the contents were the 70143662 Smart Piston but the inside package contents was the 70142158 Stapes Piston; see image below

Jul 14, 2020 Other Medical Devices View Details →

Positron Emission Tomography and Computed Tomography System, Model: uMI 550, Material Number: 88000057 - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.

Shanghai United Imaging Healthcare Co.

Class I - Dangerous

In affected software version, of Positron emission tomography and computed tomography system, the CT Hounsfield unit curve may not display in real time when using the bolus tracking protocol with the tracker scan function. If this occurs, the subsequent clinical scanning protocols will need to be started manually, which may effect image enhancement, and may result in patient rescan.

Mar 26, 2020 Other Medical Devices Nationwide View Details →

POLARSTEM COLLAR Reamer Guide, Catalog Number: 75102205, UPC Codes: 00885556535493 - Product Usage: Once the appropriate trial rasp size is in place, the adapter is removed and the calcar reamer guide (75102205) is positioned on the rasp. The calcar reamer (75102207 or 75102208) is placed over the reamer guide and the femoral neck is machined until the reamer reach the physical stop-fully seated on the inner reamer guide.

Smith & Nephew Orthopaedics AG

Class I - Dangerous

Multiple lots being recalled due to a product design issue

Jul 22, 2020 Other Medical Devices Nationwide View Details →

Golden Technologies Model Number PR515 Lift Chair - Product Usage: is to provide lift assistance for persons who have difficulty rising from a seated position to a standing position.

Golden Technologies

Class I - Dangerous

Suspect poor weld on back KD bar.

Jul 6, 2020 Other Medical Devices View Details →

Ultra/Phonic Focus BP Conforming Gel Pads, UDI 00300361301021 (Primary); 10300361301028 (Package) - Product Usage: A gel pad for use on woman s areola during an ultrasound examination. Its primary purpose is for patient comfort over the loose gel and helps with nipple location during the scan, making the areola location easier to identify.

Pharmaceutical Innovations

Class I - Dangerous

The firm registered the product as a Class I device, but has since been informed by FDA that the device is not Class I and requires a 510(k) submission.

Aug 13, 2020 Other Medical Devices Nationwide View Details →

DePuy Synthes Trauma LCP One-Third Tubular Plate with Collar 8 Holes / 93mm - Product Usage: intended for fixation of fractures, osteotomies and non-unions of clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia and fibula, particularly in osteopenic bone. Part Number 241.381

Synthes (USA) Products

Class I - Dangerous

May have one or more dimensional features out of tolerance includes: thread pitch diameter depth, thread minor diameter depth, plate thickness and end length out of tolerance that can potentially result in a reduced locking strength of an LCP screw

Jul 21, 2020 Other Medical Devices Nationwide View Details →

PAPR (Powered Air-Purifying Respirator) - Model# WLPAPR20W1

Whirlpool

Class I - Dangerous

The rivets that secure the elastic headband to the face shield have the potential to be mis-assembled. When this condition occurs, it can result in a headband that can become loose from face shield allowing the face shield to shield on the user.

Jul 2, 2020 Other Medical Devices View Details →

Cytocell LPH533-A NUP98 Distal Probe Green - Product Usage:The NUP98 Distal probe, labelled in green, consists of a 151kb probe distal to the NUP98 gene, covering the ZNF195 gene and the D11S4731 marker. Fluorescence in situ hybridisation (FISH) is a technique that allows the visualisation of DNA sequences upon chromosomes.

Cytocell

Class I - Dangerous

A low risk of a false positive result being issued with a laboratory developed test (LDT) that utilizes the LPH533-A NUP98 Distal Probe Green.

Jul 17, 2020 Other Medical Devices Nationwide View Details →

Bariatric Bed Frame System The Citadel Plus Bariatric Bed Frame System is intended for the acute and post-acute care environments. It is not intended for use in the home care environment.

ARJOHUNTLEIGH POLSKA Sp. z.o.o.

Class I - Dangerous

Modular Junction Box (MJB) cables can melt and affect the bed functionality.

Jul 21, 2020 Other Medical Devices Nationwide View Details →

Smart Stapes Protheses Piston 0.4mm X 5.25 mm- Partial Ossicular Replacement Catalog Number: 70142168

Olympus Corporation of the Americas

Class I - Dangerous

Mislabeled outer carton: packaged with the outer carton label stating the contents were the 70143662 Smart Piston but the inside package contents was the 70142158 Stapes Piston; see image below

Jul 14, 2020 Other Medical Devices View Details →

PERI-LOC TARGETER 4.5MM DISTAL FEMUR, HANDLE, LEFT, NON-STERILE - Product Usage: used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC plates and screws are indicated for fixation of pelvic, small and long bone fractures, including those of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius, calcaneus and clavicle.

Smith & Nephew

Class I - Dangerous

The 4.5MM PeriLoc Targeter right hand part was anodized green and was marked as a left-hand part.

Jun 29, 2020 Other Medical Devices Nationwide View Details →

Calcaneus Plate, Extensile, Medium, Left, Catalog Number CPF 102 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calcaneus.

Flower Orthopedics

Class I - Dangerous

The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium).

Jul 8, 2020 Other Medical Devices Nationwide View Details →

Calcaneus Plate, Extensile, Large, Right, Catalog Number CPF 203 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calcaneus.

Flower Orthopedics

Class I - Dangerous

The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium).

Jul 8, 2020 Other Medical Devices Nationwide View Details →