Z-1941-2016Class II

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

Name: Z-1941-2016 Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument set
Creator: Materialise USA LLC
Published: 2016-05-03
License: https://open.fda.gov/license/

Materialise USA, LLC. / initiated 2016-05-03 / Terminated / root cause: manufacturing process

FDA source

Materialise USA LLC began a recall of Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument set on 2016-05-03. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1941-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-03
Posted: 2016-06-09
Terminated: 2016-06-28
Recalling firm: Materialise USA, LLC.
Product: Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument set.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
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.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: Lot #154970

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1941-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1941-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-15	2016-06-09

Product code JWH

K102795Class IISignature Planner; Signature GuidesMaterialise NV / cleared 2011-02-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)