FDA Device

Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument set.

Hazard

A patient specific case of Signature Personalized Patient Care System Knee Guides included a femur guide which does not match the patient associated with the case. If the issue is not identified prior to surgery, the personalized patient specific guide would provide an improper fit and would not be able to be used.

What You Should Do

Remedy

Materialise sent an URGENT: Signature Personalized Patient Care System Knee Guides Notification dated May 3, 2016. It was sent to the affected customer via email with instructions for identifying and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Contact Materialise customer service for additional information or to find a status of the second patient specific surgical guide Monday through Friday, 8:00AM to 4:30 PM, Eastern Time.734-259-7016

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Products

Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument set.
Brand
Materialise USA LLC
UPC
Lot #154970

Units Affected

1

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