Home / Recalls / Pega Medical Inc. / Z-1448-2014

Z-1448-2014 Class II Terminated

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

Recall Details

Product Type: Devices
Report Date: April 16, 2014
Initiation Date: February 7, 2014
Termination Date: April 23, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: Total of 5 units (2 units in the US and 3 units in Germany)

Product Description

Pega Medical Inc., Fassier-Duval IM Telescopic System, male component (solid shaft), Part number: M040-SS-110; Used in Implant Catalogue number: FD-040(LS)-SS. orthopedic intramedullary rod.

Reason for Recall

The Male Components in this lot are made of material with lower strength than manufacturing specifications.

Distribution Pattern

Worldwide Distribution - USA Nationwide in the states of Missouri, Texas, and the country of Germany.

Code Information

Lot #: 130424-15 (only laser marked on the Part Number: M040-SS-110); Lot #: 121109-11 &130424-15 [Indicated on the label of the Catalogue Number: FD-040(L)-SS].

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-1472-2014 Class II — Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. Cat (March 5, 2014)