Pega Medical Inc.

FDA recalling firm · 9 enforcement events · 9 product records · 2014–2020 · N/A

Pega Medical Inc. has 9 FDA enforcement events on this register (9 product records) between 2014 and 2020: 9 device; the busiest year was 2015 with 4.

0% of its events are Class I; the most common class is Class II (8). 0 events are listed as ongoing; the recalling firm's address is in N/A.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
3 Apr 2020	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.	Device	Class III	1	Terminated
2 Oct 2019	SCFE (slipped capital femoral epiphysis) Knobs for Driver, 6.5mm and 7.3 mm Orthopedic surgical instrument component, for hip surgery	Device	Class II	1	Terminated
29 May 2019	SLIM Handle - catalogue #: SLM-HND100 a component of Simple Locking Intramedullary (SLIM) System	Device	Class II	1	Terminated
20 Oct 2015	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-Gliding SCFE Screw System is a temporary…	Device	Class II	1	Terminated
15 Jun 2015	Slipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE Screw System with catalogue number SCF-MLD265 and SCF-MLD273.	Device	Class II	1	Terminated
10 Apr 2015	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 number and lot number.	Device	Class II	1	Terminated
20 Feb 2015	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 humerus of pediatric patients, who have…	Device	Class II	1	Terminated
5 Mar 2014	Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. Catalogue number FD-040(L)-SS. -Duval IM Telescopic System.	Device	Class II	1	Terminated
7 Feb 2014	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.	Device	Class II	1	Terminated

By type and class

Device9

Class II8

Class III1

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Pega Medical Inc. by year initiated.

Questions and answers

How many FDA recalls has Pega Medical Inc. had?

9 enforcement events (9 product records) on this register, 2014–2020: 9 device.

Are any Pega Medical Inc. recalls ongoing?

0 events are listed as ongoing in the current openFDA export.

What class are Pega Medical Inc. recalls?

8 Class II, 1 Class III. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.