RegWardenFDA facility compliance records
Company

Pega Medical Inc.

9 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2014: 2 recalls; 2015: 4 recalls; 2019: 2 recalls; 2020: 1 recalls2’144’15’16’17’182’191’20’21’22’23’24’25’26
  • Recalls (9)

Registered facilities (1)

Recalls & enforcement

  • Class IIITerminated2020-04-03
    The lot number on the pediatric orthopedic implant driver instrument handle does not match the lot number on the label.
  • Class IITerminated2019-10-02
    There is a potential for the screws to have become loosened during ultrasonic cleaning of the knobs and the screws may come out.
  • Class IITerminated2019-05-29
    Handle could jam with the Driver due to the detachment of an internal Connector Ring.
  • Class IITerminated2015-10-20
    SCFE Driver's threaded shaft broke close to the knob when a manual force was applied during the fixation of the screw.
  • Class IITerminated2015-06-15
    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.
  • Class IITerminated2015-04-10
    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.
  • Class IITerminated2015-02-20
    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 tib…
  • Class IITerminated2014-03-05
    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.
  • Class IITerminated2014-02-07
    The Male Components in this lot are made of material with lower strength than manufacturing specifications.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Pega Medical Inc. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10027933-pega-medical-inc/

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