International Medical Devices Database

Manufacturer Address
Materialise N.V., 15 Technologielaan, Heverlee Belgium
Manufacturer Parent Company (2017)
Materialise Nv
Source
USFDA
2 Events
- Recall of Signature Patient Specific Surgical Guides
- Recall of Device Recall Materialise Distributed by Biomet Orthopedics, Signature Personalized Patient Care System

2 devices in the database

Signature Patient Specific Surgical Guides

Model / Serial
42422461: Signature SIG CT/TI(A Guides 04-05 Slidex Distal-MP/Premier Tibial & 42422551 : Signature TKA GDE/MDL SET 03-05 MP/Premier Distal- MP/Premier Tibial 42422461 139540 2016-02-17 42-422551 1 391 51 2016-01-14 42422551 1 38805 2016-02-03 42-422551 140787 2016-03-03
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
No
Distribution
Distributed in MI, ID, TX, and in France.
Product Description
Signature Patient-Specific Surgical Guides; patient specific instruments used as a guide during surgical procedure for total and partial knee arthroplasty. Part of the Signature Personalized Patient Care System.

Device Recall Materialise Distributed by Biomet Orthopedics, Signature Personalized Patient Care...

Model / Serial
Lot# 124471
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Worldwide Distribution to the Netherlands only.
Product Description
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.

One manufacturer with a similar name

Learn more about the data here

MATERIALISE N.V.

Manufacturer Address
LEUVEN
Manufacturer Parent Company (2017)
Materialise Nv
Source
HC

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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Materialise N.V.

2 devices in the database

Signature Patient Specific Surgical Guides

Device Recall Materialise Distributed by Biomet Orthopedics, Signature Personalized Patient Care...

One manufacturer with a similar name

MATERIALISE N.V.