Standard Offset Cup Impactor (2015-05-12)

Starting date:

May 12, 2015

Posting date:

June 3, 2015

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-53655

• Reason
• Affected products

Recalled Products

A. Standard Offset Cup Impactor

Reason

Greatbatch had originally identified through internal sterility assurance level validation testing that a sterility assurance level of 10-6 is not achieved on the standard offset cup impactor when it is subjected to the steam sterilization cycles and associated dry times that are specified in the current Instructions for Use (IFU) provided with the device. The standard offset cup impactor is provided non-sterile and must be sterilized prior to use in a surgery. Stryker orthopedics then took additional risk mitigation steps to include the removal of the blue plastic handle. All modified units (T6318) are now being removed from the field.

Affected products