Z-1287-2015Class II

Signature TKA GDE/MDL Set 04-05 (Femur & Tibia) The Signature Patient-Specific Surgical Guides are intended...

Name: Z-1287-2015 Signature TKA GDE/MDL Set 04-05 (Femur & Tibia) The Signature Patient-Specific Surgical Guides are intended...
Creator: Materialise N.V.
Published: 2015-02-04
License: https://open.fda.gov/license/

Materialise N.V. / initiated 2015-02-04 / Terminated / root cause: manufacturing process

FDA source

Materialise N.V. began a recall of Signature TKA GDE/MDL Set 04-05 (Femur & Tibia) The Signature Patient-Specific Surgical Guides are intended to be used as part of the Signature Personalized... on 2015-02-04. FDA classified it as Class II and gives the reason as "Images belonging to a different patient were used for the production of the patient specific surgical guide. The incorrect guide may cause a delay in surgery to accommodate the preparation and use of traditional...". 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-1287-2015
Classification: Class II
Status: Terminated
Initiated: 2015-02-04
Posted: 2015-03-17
Terminated: 2015-10-30
Recalling firm: Materialise N.V.
Product: Signature TKA GDE/MDL Set 04-05 (Femur & Tibia) The Signature Patient-Specific Surgical Guides are intended to be used as part of the Signature Personalized Patient Care System. Lt is intended to be used as a guide during the surgical procedure for total and partial knee arthroplasty.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Images belonging to a different patient were used for the production of the patient specific surgical guide. The incorrect guide may cause a delay in surgery to accommodate the preparation and use of traditional instrumentation.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Materialise N.V. sent an email on February 4, 2015, to the the affected distributor regarding the reason for the recall, affected product, and instructions for removing the affected product. For questions regarding this recall call 321-639-6611.
Quantity in commerce: 1 unit
Distribution: Worldwide Distribution to the Netherlands only.
Product codes and lots: Lot# 124471

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1287-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1287-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-25	2015-03-17

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)