Home / Recalls / Pega Medical Inc. / Z-1472-2014

Z-1472-2014 Class II Terminated

Recalled by Pega Medical Inc. — Laval, N/A

Recall Details

Product Type
Devices
Report Date
April 30, 2014
Initiation Date
March 5, 2014
Termination Date
May 19, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
48

Product Description

Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. Catalogue number FD-040(L)-SS. -Duval IM Telescopic System.

Reason for Recall

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.

Distribution Pattern

Worldwide distribution, USA nationwide, Greece, United Arab Emirates, Peru, Canada, Israel, United Kingdom, France, Germany, Colombia, Mexico, Singapore, Lithuania, Denmark, and Spain.

Code Information

Catalogue Number: FD-040(L)-SS Lot #: 111208-03 and 110808-13 111019-01 and 110808-13 110302-01 and 110808-13

Other recalls by Pega Medical Inc.

  • Z-2038-2020 Class III — Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medullary (April 3, 2020)
  • Z-0270-2020 Class II — SCFE (slipped capital femoral epiphysis) Knobs for Driver, 6.5mm and 7.3 mm Ort (October 2, 2019)
  • Z-2278-2019 Class II — SLIM Handle - catalogue #: SLM-HND100 a component of Simple Locking Intramedulla (May 29, 2019)
  • Z-0324-2016 Class II — SCFE Driver (SCF-MLD273 & SCF-MLD265) instrument used for the insertion of the F (October 20, 2015)
  • Z-1848-2015 Class II — Slipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE Screw (June 15, 2015)
  • Z-1546-2015 Class II — Female Driver, Part number FDr101, instrument used for the insertion of the Fass (April 10, 2015)
  • Z-1362-2015 Class II — GAP Nail 4.8mm (diameter size) of the GAP ENDO-EXO MEDULLARY SYSTEM. Catalog nu (February 20, 2015)
  • Z-1448-2014 Class II — Pega Medical Inc., Fassier-Duval IM Telescopic System, male component (solid sha (February 7, 2014)