T7 Cannulated Driver AO, T7 Driver Solid AO (2019-04-03)

Starting date:

April 3, 2019

Posting date:

April 12, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-69574

Last updated: 2019-04-12

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  Reason
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  Affected products

Affected Products

1. T7 Cannulated Driver AO
2. T7 Driver Solid AO

Reason

Zimmer Biomet is conducting a removal of the T7 Cannulated Driver AO and T7 Driver Solid AO due to the potential of fracture, bending or shearing of the T7 Driver. The T7 Driver is being redesigned. All distributed product remaining in the field is being removed. The T7 drivers will be replaced with a new design with new part numbers (T7 Cannulated Driver AO PN: 110038661 and T7 Solid Driver AO PN:110038662). This letter also serves as a notice for the discontinuation of the current design product.

Affected products