HP LCS IM Hole Locator Instrument (2015-01-23)

Starting date:

January 23, 2015

Posting date:

February 16, 2015

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-43721

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  Reason
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  Affected products

Recalled Products

A) HP LCS IM Hole Locator Instrument (2015-01-23)

Reason

Depuy Orthopaedics is issuing a device correction for all lots of HP LCS intramedullary (IM) hole locator instruments because the Japanese market has reported eight instances where femoral fractures occurred intra-operatively during primary knee replacement surgery while using the instrument. The company is not requesting the return of the device. This communication is to highlight and expand upon information from the appropriate surgical technique which states that the device may be lightly impacted for additional stability.

Affected products