The lot number on the pediatric orthopedic implant driver instrument handle does not match the lot number on the label.
Pega Medical
9 recalls • • Categories: Surgical Instruments, Implants & Prosthetics, Other Medical Devices, Infusion Pumps
Class I - Dangerous
There is a potential for the screws to have become loosened during ultrasonic cleaning of the knobs and the screws may come out.
Class I - Dangerous
Handle could jam with the Driver due to the detachment of an internal Connector Ring.
SCFE Driver's threaded shaft broke close to the knob when a manual force was applied during the fixation of the screw.
Class I - Dangerous
SCFE Drivers of the Free-Gliding SCFE Screw System are recalled because the handle of the instruments may detach from the shaft if high torques are applied in counter-clockwise rotation.
The hexagonal tip of the Female Driver instrument for the Fassier-Duval IM Telescopic System is 0.06 mm under the specifications. This may result in a reduction of the total strength of the instrument, possibly leading to deformation, wear, and tip breakage.
Failures of the 4.8mm of the GAP Endo-Exo Medullary System have been identified at the level of the distal cortical screw holes. Failures mainly occurred in patients with tibial pseudoarthrosis (CPT) or Osteogenesis imperfecta (OI). Higher failure rates have been detected in tibias with distal fractures that are close to the distal locking holes.
Class I - Dangerous
The outer package label contained the incorrect length of the device. There is a label on the outer package and an additional label on the product contained in the package.
The Male Components in this lot are made of material with lower strength than manufacturing specifications.