Home / Recalls / Pega Medical Inc. / Z-1848-2015

Z-1848-2015 Class II Terminated

Recalled by Pega Medical Inc. — Laval

Recall Details

Product Type
Devices
Report Date
July 8, 2015
Initiation Date
June 15, 2015
Termination Date
December 29, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4 units

Product Description

Slipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE Screw System with catalogue number SCF-MLD265 and SCF-MLD273.

Reason for Recall

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.

Distribution Pattern

US Distribution to the states of : FL and TN.

Code Information

Part Number: SCF-MLD265, LOT#: 130703-01. Part Number: SCF-MLD273, LOT#: 130703-02.

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-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-1472-2014 Class II — Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. Cat (March 5, 2014)
  • Z-1448-2014 Class II — Pega Medical Inc., Fassier-Duval IM Telescopic System, male component (solid sha (February 7, 2014)