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.
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Implants & Prosthetics
ðĨ Medical Devices âĒ 4,540 recalls
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.
Monitor Ceiling Suspension system may fall
The firm had received a complaint alleging that a medical professional had difficulty inserting a guide wire into a needle
Monitor Ceiling Suspension system may fall
Class I - Dangerous
Medtronic has confirmed an issue with InSync III CRT-pacemaker devices related to long-term battery performance. The root cause is unexpected high battery impedance.
Monitor Ceiling Suspension system may fall
Class I - Dangerous
Stryker Orthopaedics has received two customer complaints regarding Duracon Tibial Wedge implants puncturing the packaging's Tyvek lid(s).
Radiesse (+) Lidocaine Injectable Implant 1.5cc, P/N: 8063M0K1. Indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds.
Merz North America
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.
Monitor Ceiling Suspension system may fall
Class I - Dangerous
It was identified by a customer complaint that some I.V. poles were retracting/lowering from an extended position to the low height unexpectedly. An investigation was initiated which identified that the I.V. Latch Housing was nonconforming. potential hazards: " Suspended I.V. pole retracts unexpectedly " Suspended I.V. pole retracts unexpectedly with pump/bags attached