The Recall Desk

Manufacturer

Pega Medical Inc.

9 recalls in our database name Pega Medical Inc. as the manufacturing or recalling firm.

What the numbers show

Total
9
Critical
0
Severe
2
Most recent
2020-05-27

Of the 9 recalls from Pega Medical Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (22%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–9 of 9

  • LowFDA (Devices)·Z-2038-2020·2020-05-27

    Pega Medical Recalls SLIM System Handle Due to Lot Number Mismatch

    Pega Medical Inc. is recalling three units of the SLIM System handle because the lot number on the instrument does not match the packaging label.

    Product
    Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medullary (SLIM) System - Product Usage: The SLIM handle is the grip for the SLIM driver in orthopedic surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0270-2020·2019-11-13

    Pega Medical Recalls SCFE Knobs for Driver Due to Screw Loosening Risk

    Pega Medical Inc. is recalling 31 SCFE Knobs for Driver because screws may loosen during ultrasonic cleaning and fall out.

    Product
    SCFE (slipped capital femoral epiphysis) Knobs for Driver, 6.5mm and 7.3 mm Orthopedic surgical instrument component, for hip surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2278-2019·2019-08-21

    Pega Medical Recalls SLIM Handle Components Due to Jamming Risk

    Pega Medical Inc. is recalling 19 SLIM Handle components because an internal ring may detach, causing the handle to jam with the driver.

    Product
    SLIM Handle - catalogue #: SLM-HND100 a component of Simple Locking Intramedullary (SLIM) System
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0324-2016·2015-12-02

    Pega Medical Recalls SCFE Driver Instruments Due to Threaded Shaft Breakage

    Pega Medical Inc. is recalling 4 SCFE Driver instruments distributed in Florida and Tennessee because the threaded shaft broke during use.

    Product
    SCFE Driver (SCF-MLD273 & SCF-MLD265) instrument used for the insertion of the Free Gliding SCFE Screw System. This instrument is included in the Free Gliding SCFE Screw System instrument tray. This instrument is marked with the catalogue number and lot number. The Free-
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1848-2015·2015-07-08

    Pega Medical Recalls SCFE Drivers Due to Handle Detachment Risk

    Pega Medical Inc. is recalling four units of SCFE Drivers because the handle may detach from the shaft during use.

    Product
    Slipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE Screw System with catalogue number SCF-MLD265 and SCF-MLD273.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1546-2015·2015-05-06

    Pega Medical Recalls Female Driver Instruments for Orthopedic Procedures

    Pega Medical Inc. is recalling 9 Female Driver instruments used in orthopedic procedures because the hexagonal tip is 0.06 mm under specifications, which may lead to breakage.

    Product
    Female Driver, Part number FDr101, instrument used for the insertion of the Fassier-Duval IM Telescopic System. For orthopedic procedures. This instrument is included in the Fassier-Duval IM Telescopic System instrument tray. This instrument is marked with the catalogue num
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Devices)·Z-1362-2015·2015-04-08

    Pega Medical Recalls GAP Nail 4.8mm Due to Distal Screw Hole Failures

    Pega Medical Inc. is recalling 7 units of the 4.8mm GAP Nail because of failures at the distal cortical screw holes, primarily in patients with specific bone conditions.

    Product
    GAP Nail 4.8mm (diameter size) of the GAP ENDO-EXO MEDULLARY SYSTEM. Catalog number GAP-N48-16; GAP-N48-18; GAP-N48-26; GAP-N48-28. Product Usage: The GAP Endo-Exo Medullary System is used for the treatment of fractures or correction of deformities in the femur, tibia and hu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1472-2014·2014-04-30

    Pega Medical Recalls Fassier-Duval IM Telescopic System Due to Labeling Error

    Pega Medical Inc. is recalling 48 units of the Fassier-Duval IM Telescopic System because the outer package label listed the incorrect device length.

    Product
    Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. Catalogue number FD-040(L)-SS. -Duval IM Telescopic System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1448-2014·2014-04-16

    Pega Medical Recalls Fassier-Duval Intramedullary Rods Due to Material Defect

    Pega Medical Inc. is recalling five units of the Fassier-Duval IM Telescopic System because the male components were made with material of lower strength than specifications.

    Product
    Pega Medical Inc., Fassier-Duval IM Telescopic System, male component (solid shaft), Part number: M040-SS-110; Used in Implant Catalogue number: FD-040(LS)-SS. orthopedic intramedullary rod.
    Category
    Medical Device
    Distribution
    Distributed nationwide