Pega Medical Recalls
9 recalls on record · April 16, 2014 to May 27, 2020 · Medical Devices
Recalls by year
14
15
19
20
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
May 27, 2020Medical DevicesFDA
Pega Medical Inc. recalls Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medullary (SLIM) System - Product Usage: The SLIM
Hazard: The lot number on the pediatric orthopedic implant driver instrument handle does not match the lot number on the label.
November 13, 2019Medical DevicesFDA
Pega Medical Inc. recalls SCFE (slipped capital femoral epiphysis) Knobs for Driver, 6.5mm and 7.3 mm Orthopedic surgical instrument component, f
Hazard: There is a potential for the screws to have become loosened during ultrasonic cleaning of the knobs and the screws may come out.
August 21, 2019Medical DevicesFDA
Pega Medical Inc. recalls SLIM Handle - catalogue #: SLM-HND100 a component of Simple Locking Intramedullary (SLIM) System
Hazard: Handle could jam with the Driver due to the detachment of an internal Connector Ring.
December 2, 2015Medical DevicesFDA
Pega Medical Inc. recalls SCFE Driver (SCF-MLD273 & SCF-MLD265) instrument used for the insertion of the Free Gliding SCFE Screw System. This
Hazard: SCFE Driver's threaded shaft broke close to the knob when a manual force was applied during the fixation of the screw.
July 8, 2015Medical DevicesFDA
Pega Medical Inc. recalls Slipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE Screw System with catalogue number SCF-MLD265
Hazard: 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.
May 6, 2015Medical DevicesFDA
Pega Medical Inc. recalls Female Driver, Part number FDr101, instrument used for the insertion of the Fassier-Duval IM Telescopic System. For ort
Hazard: 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.
April 8, 2015Medical DevicesFDA
Pega Medical Inc. recalls GAP Nail 4.8mm (diameter size) of the GAP ENDO-EXO MEDULLARY SYSTEM. Catalog number GAP-N48-16; GAP-N48-18; GAP-N48-26;
Hazard: 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.
April 30, 2014Medical DevicesFDA
Pega Medical Inc. recalls Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. Catalogue number FD-040(L)-SS.
Hazard: 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.
April 16, 2014Medical DevicesFDA
Pega Medical Inc. recalls Pega Medical Inc., Fassier-Duval IM Telescopic System, male component (solid shaft), Part number: M040-SS-110; Used in
Hazard: The Male Components in this lot are made of material with lower strength than manufacturing specifications.