Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint,
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Implants & Prosthetics
ðĨ Medical Devices âĒ 4,589 recalls
Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint,
Inadequate biocompatibility testing.
Inadequate biocompatibility testing.
The 16 devices distributed in the United States were incorrectly labeled as the monoblock Birmingham Hip Modular Head, with labeling not cleared for marketing in the US. The actual devices were monoblock Modular Femoral Head for hemiarthroplasty use.
Class I - Dangerous
Images contained within radiographic transparency ART 1036 are undersized.
Class I - Dangerous
The flexible shaft of the instruments may break during orthopedic spinal surgery. There is a risk of a delay in surgery or that a fragment from the shaft could be left in a patient.
Class I - Dangerous
The flexible shaft of the instruments may break during orthopedic spinal surgery. There is a risk of a delay in surgery or that a fragment from the shaft could be left in a patient.
Class I - Dangerous
Complaints were received from Thailand reporting that there was no white paper (Tyvek) seal on the inner package of P/N:00-5980-037-01 unit from lot #62460264
The flexible shaft of the instruments may break during orthopedic spinal surgery. There is a risk of a delay in surgery or that a fragment from the shaft could be left in a patient.
DA-2006P - Defibrillator / Pacer Analyzer; Product Usage: Intended to measure the output of a defibrillator or transcutaneous pacemaker.
BC Group International
Class I - Dangerous
Device is not functioning as intended: Two wires running to the ECG distribution circuit board are reversed resulting in inverted waveforms.
Class I - Dangerous
The flexible shaft of the instruments may break during orthopedic spinal surgery. There is a risk of a delay in surgery or that a fragment from the shaft could be left in a patient.
DGDE, DirectGuide Drill Extender. Instrument for use with dental implants. A manufactured device that adds a 6mm extension for a 25mm and 28mm tissue height capability suitable for individual patient needs. The thru hole in the DGDE allows existing surgical drills to be inserted and locked in place.
Implant Direct Sybron Manufacturing
Class I - Dangerous
Implant Direct Sybron Manufacturing, LLC is recalling 26 lots of DGDE DirectGuide Drill Extender because of a possible dropping of the drill.
Class I - Dangerous
Complaints that the ratchet teeth of the tube are not latching onto the rod.
RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx only, Sterile R, BIOHORIZONS(R), Dental Implant
BioHorizons Implant Systems
Class I - Dangerous
An incorrect label reading 10.5mm and not the specified 15mm was placed on the implant inner vial packaging.
Class I - Dangerous
Complaints that the ratchet teeth of the tube are not latching onto the rod.
Monitor Ceiling Suspension system may fall
Monitor Ceiling Suspension system may fall
Monitor Ceiling Suspension system may fall
Class I - Dangerous
The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect.