#3 Goldstein Flexi-Thin Composite Instrument and parts (2016-05-23)

Starting date:

May 23, 2016

Posting date:

June 24, 2016

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-58918

• 
  Reason
• 
  Affected products

Affected products

1. #3 Goldstein In Flexi-thin Composite Instrument
2. CIGFT3 Stainless Steel #3 Goldstein flexi thin composite instrument #41 handle
3. CIGFT36 Stainless Steel #3 Goldstein Flexi-Thin Composite Instrument, #6 handle
4. CIGFT38 Stainless Steel #3 Goldstein Flexi-Thin Composite Instrument, #8 handle

Reason

The company recorded a higher rate of returns for this product for breakage compared to the historic average. The company analyzed the mode of failure and identified an opportunity to improve the manufacturing process for this item. The company wishes to replace product in the field to lessen the chance of customer dissatisfaction.

Affected products