Materialise USA

6 recalls •

🏥 Medical Devices

• Categories: Other Medical Devices, Surgical Instruments, Implants & Prosthetics

ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208

Class I - Dangerous

MU22-INA-DUQ case was labeled as MU22-INA-DUQ but was shipped with the Anatomical Model of case MU22-NOF-SAK

Jul 13, 2022 Other Medical Devices Nationwide View Details →

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

Class I - Dangerous

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.

May 3, 2016 Surgical Instruments View Details →

Zimmer Patient Specific Instrument PERSONA CR Pin Guides (Femur and Tibia) is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

Class I - Dangerous

The box of guides for a specific case arrived intact but contained two (2) femoral guides instead of one (1) femoral guide and one (1) tibial guide. The device did not meet specification: One tibia guide missing and one femur guide contained an edge which was +0.04 mm over specification.

Oct 16, 2014 Implants & Prosthetics Nationwide View Details →

REF 42-411571 QTY 1 CATALOG CAUTION. SEE INSTRUCTIONS FOR USE SIGNATURE M PKA GDE/MDL SET SML-MP DD.....R-FEB55RKA-T JA-A01 05551 PKA POST CUT SML-PKA MICROPLASTY CUSTOM-MADE DEVICE non-sterile The Signature Personalized Patient Care System includes the patient-specific Signature Guides which are patient specific instruments (guides are considered custom-made per EU definition) intended for use during the surgical procedure for total and partial knee arthroplasty.

Class I - Dangerous

Shipped femur guide contained a non-conformance which could possibly impact fit of the drill insert.

Nov 26, 2013 Implants & Prosthetics View Details →

ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Final Single Use Only Rx only. Used as surgical tools to transfer a pre-operative plan to surgery. .

Class I - Dangerous

Patient Specific Guide contained the incorrect case report. The case report contains patient specific surgical plan information.

Nov 8, 2013 Surgical Instruments View Details →

ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Intermediate Single Use Only Rx only. Used as surgical tools to transfer a pre-operative plan to surgery.

Class I - Dangerous

Patient Specific Guide contained the incorrect case report. The case report contains patient specific surgical plan information.

Nov 8, 2013 Surgical Instruments View Details →