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Z-2278-2019 Class II Terminated

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

FDA device recall Z-2278-2019 was initiated by Pega Medical Inc. on May 29, 2019 and is designated Class II. Reason for recall: Handle could jam with the Driver due to the detachment of an internal Connector Ring. The recall status is terminated (terminated January 15, 2021). Affected quantity: 19.

Recall Details

Product Type
Devices
Report Date
August 21, 2019
Initiation Date
May 29, 2019
Termination Date
January 15, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
19

Product Description

SLIM Handle - catalogue #: SLM-HND100 a component of Simple Locking Intramedullary (SLIM) System

Reason for Recall

Handle could jam with the Driver due to the detachment of an internal Connector Ring.

Distribution Pattern

CA, DE, FL, IL, NC, NE, NY and TN

Code Information

Lot # 150115-09, 160427-01 and A162-02

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-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)

FDA data resources