Home / Recalls / Pega Medical Inc. / Z-2038-2020

Z-2038-2020 Class III Terminated

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

Recall Details

Product Type
Devices
Report Date
May 27, 2020
Initiation Date
April 3, 2020
Termination Date
November 20, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3 units

Product Description

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.

Reason for Recall

The lot number on the pediatric orthopedic implant driver instrument handle does not match the lot number on the label.

Distribution Pattern

US Nationwide Distribution including in the states of Florida. No Foreign Consignees listed.

Code Information

SLIM Handle with Catalog #SLM-HND100 with etched lot code #B204-1 on the handle and with Lot# B204-01 on the packaging label.

Other recalls by Pega Medical Inc.

  • 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-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)