Pega Medical, Inc.
CanadaFDA applicant, unverified
- Devices
- 12
- FDA recalls
- 10
At a glance
Market reach
- United States
- FDA recalls
What Pega Medical, Inc. makes
Pega Medical, Inc. manufactures orthopedic fixation devices for pediatric and adolescent bone disorders, including intramedullary systems for slipped capital femoral epiphysis (SCFE), telescopic implants for limb lengthening, and proximal femoral plating systems. Their portfolio includes gap endo-exo medullary systems for bone stabilization, a simple locking intramedullary (Slim) system for femoral fractures, and hinge plating systems for complex pediatric orthopedic cases.
The company’s devices are classified as Class II under FDA regulations and are submitted for clearance via the 510(k) pathway. These products are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
Search and filter all 12 devicesFDA recalls
FDA recall records list 10 recalls initiated by Pega Medical, Inc., the earliest on 2010-01-29 and the most recent on 2020-04-03. By recorded status: 10 terminated. The reasons filed fall into these groups: labeling or instructions for use, packaging, mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 2
- 2020 1
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2020
- 3 Apr 2020 Z-2038-2020 Class III Terminated The lot number on the pediatric orthopedic implant driver instrument handle does not match the lot number on the label.
2019
- 2 Oct 2019 Z-0270-2020 Class II Terminated There is a potential for the screws to have become loosened during ultrasonic cleaning of the knobs and the screws may come out.
Full distribution text
- 29 May 2019 Z-2278-2019 Class II Terminated Handle could jam with the Driver due to the detachment of an internal Connector Ring.
- 2 Oct 2019 Z-0270-2020 Class II Terminated There is a potential for the screws to have become loosened during ultrasonic cleaning of the knobs and the screws may come out.
2015
- 20 Oct 2015 Z-0324-2016 Class II Terminated SCFE Driver's threaded shaft broke close to the knob when a manual force was applied during the fixation of the screw.
- 15 Jun 2015 Z-1848-2015 Class II Terminated 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.
- 10 Apr 2015 Z-1546-2015 Class II Terminated 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.
- 20 Feb 2015 Z-1362-2015 Class II Terminated 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.
2014
- 5 Mar 2014 Z-1472-2014 Class II Terminated 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.
Full distribution text
- 7 Feb 2014 Z-1448-2014 Class II Terminated The Male Components in this lot are made of material with lower strength than manufacturing specifications.
- 5 Mar 2014 Z-1472-2014 Class II Terminated 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.
2010
- 29 Jan 2010 Z-1494-2011 Unclassified (pre-2012) Terminated Possible breakage. Structural weakness has been detected on the Male Driver 3.2mm and 4.0mm sizes. In certain cases, this weakness could lead to a premature failure of the instrument if it is submitted to large torsional loads higher than the normal forces required to introduce the male component.
Frequently asked questions
How many devices does Pega Medical, Inc. have in the registry?
The registry currently lists 12 devices for Pega Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Pega Medical, Inc.'s devices?
Among its 12 most recently registered devices, Pega Medical, Inc. has devices listed in FDA 510(k) (12 devices).
What risk classes do Pega Medical, Inc.'s devices fall under?
Among its 12 most recently registered devices, the classes recorded for Pega Medical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Pega Medical, Inc.?
FDA recall records list 10 recalls initiated by Pega Medical, Inc., the most recent initiated on 3 Apr 2020. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Pega Medical, Inc. in the registry?
The most recently registered devices listed for Pega Medical, Inc. include The Locking Pediatric Osteotomy Plate (LolliPOP) System, The GIRO Growth Modulation System, FREE GLIDING SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREW (SCFE) and GAP ENDO-EXO MEDULLARY SYSTEM.