Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument set.
FDA Recall Z-1941-2016 · Posted None
Recalling FirmMaterialise USA LLC
Recall StatusTerminated
Product CodeJWH
Date Initiated2016-05-03
Date Terminated2016-06-28
Product Quantity1
Reason for Recall
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.
Firm Action
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
Root Cause
Process control
Distribution Pattern
One consignee, Indiana.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.