| Class 2 Device Recall Signature Personalized Patient Care System |  |
Date Initiated by Firm | May 03, 2016 |
Create Date | June 09, 2016 |
Recall Status1 |
Terminated 3 on June 28, 2016 |
Recall Number | Z-1941-2016 |
Recall Event ID |
74213 |
510(K)Number | K102795 |
Product Classification |
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
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Product | Signature TKA GDE/MDL Set 04-05
Patient-specific surgical guide and instrument set. |
Code Information |
Lot #154970 |
Recalling Firm/ Manufacturer |
Materialise USA LLC 44650 Helm Ct Plymouth MI 48170-6061
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For Additional Information Contact | Customer Service 734-259-7016 |
Manufacturer 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. |
FDA Determined Cause 2 | Process control |
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 |
Quantity in Commerce | 1 |
Distribution | One consignee, Indiana. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = JWH
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