Home / Recalls / Pega Medical Inc. / Z-0270-2020

Z-0270-2020 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
November 13, 2019
Initiation Date
October 2, 2019
Termination Date
October 26, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
31 devices

Product Description

SCFE (slipped capital femoral epiphysis) Knobs for Driver, 6.5mm and 7.3 mm Orthopedic surgical instrument component, for hip surgery

Reason for Recall

There is a potential for the screws to have become loosened during ultrasonic cleaning of the knobs and the screws may come out.

Distribution Pattern

Nationwide distribution to CA, FL, GA, HI, LA, MA, MO, NC, NY, OK. International distribution to AUSTRALIA, CANADA, DENMARK, GERMANY, ISRAEL, MEXICO, ROMANIA, RUSSIA, UNITED ARAB EMIRATES, UNITED KINGDOM

Code Information

Catalogue Numbers: SCF-KNB265, SCF-KNB273, SCF-KNB365, SCF-KNB373; Lot Numbers: 160428-03, 160428-04, A182-05, A182-15, 160603-05, 160603-06, A183-06

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-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-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)