CanadaThe Catalyft PL Expandable Interbody System interbody cage (models/catalogue numbers 6069096, 6069113, 6068113, 6069076, 6068076, 6068116, 6068073, 6069116, 6068096, 6069073, 6069093, 6068093; all lots) by Medtronic Sofamor Danek USA is affected. It was recalled because of the potential for loss of lordosis and updates to the surgical technique and instructions for use to add certain adverse events. Contact the manufacturer for additional information.
What's being recalled
Companies: Medtronic Sofamor Danek Usa, Inc., 1800 Pyramid Place, Memphis, Tennessee, United States, 38132.
How to identify it
Affected products: Catalyft™ PL Expandable Interbody System, Interbody Cage; Lot or serial number: All lots.; Model or catalogue number: 6069096
Affected products: Catalyft™ PL Expandable Interbody System, Interbody Cage; Lot or serial number: All lots.; Model or catalogue number: 6069113
Affected products: Catalyft™ PL Expandable Interbody System, Interbody Cage; Lot or serial number: All lots.; Model or catalogue number: 6068113
Affected products: Catalyft™ PL Expandable Interbody System, Interbody Cage; Lot or serial number: All lots.; Model or catalogue number: 6069076
Affected products: Catalyft™ PL Expandable Interbody System, Interbody Cage; Lot or serial number: All lots.; Model or catalogue number: 6068076
Affected products: Catalyft™ PL Expandable Interbody System, Interbody Cage; Lot or serial number: All lots.; Model or catalogue number: 6068116
Affected products: Catalyft™ PL Expandable Interbody System, Interbody Cage; Lot or serial number: All lots.; Model or catalogue number: 6068073
Affected products: Catalyft™ PL Expandable Interbody System, Interbody Cage; Lot or serial number: All lots.; Model or catalogue number: 6069116
Affected products: Catalyft™ PL Expandable Interbody System, Interbody Cage; Lot or serial number: All lots.; Model or catalogue number: 6068096
Affected products: Catalyft™ PL Expandable Interbody System, Interbody Cage; Lot or serial number: All lots.; Model or catalogue number: 6069073
Affected products: Catalyft™ PL Expandable Interbody System, Interbody Cage; Lot or serial number: All lots.; Model or catalogue number: 6069093
Affected products: Catalyft™ PL Expandable Interbody System, Interbody Cage; Lot or serial number: All lots.; Model or catalogue number: 6068093
The hazard
This notification is to inform customers of the potential for loss of lordosis and ensure that they are aware of updates that Medtronic is making to the surgical technique and the addition of certain adverse events to the instructions for use (IFU).
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)