Materialise Recalls Signature TKA Surgical Guides Due to Incorrect Patient Images
Materialise N.V. is recalling Signature TKA GDE/MDL Set 04-05 surgical guides because images from a different patient were used for production.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The source text states the hazard is a delay in surgery rather than direct physical injury, fitting the criteria for moderate severity.
Plain-English summary
Materialise N.V. is recalling the Signature TKA GDE/MDL Set 04-05 (Femur & Tibia) patient-specific surgical guides. These guides are intended to be used as part of the Signature Personalized Patient Care System during total and partial knee arthroplasty procedures.
The recall was initiated because images belonging to a different patient were used for the production of the patient-specific surgical guide. The use of incorrect guides may cause a delay in surgery to accommodate the preparation and use of traditional instrumentation.
The affected product is identified by Lot# 124471. The distribution pattern is listed as worldwide distribution to the Netherlands only. No specific dates or unit counts are provided in the source text.
The recalled product
- 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 arthr
- Manufacturer
- Materialise N.V.
- Category
- Medical Device — Surgical Guides
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot# 124471
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · Materialise N.V.
See all →- HighProPlan CMF Mandible Surgical Guides Recall for Wrong Version
FDA (Devices) · 2023-08-09
- HighMRI Biomet Pin Guide for Knee Surgery Shipped to Wrong Patient
FDA (Devices) · 2023-07-26
- LowMatch Point System surgical instrument recalled due to incorrect procedure side labeling
FDA (Devices) · 2020-09-02
- ModerateMaterialise Recalls TRUMATCH Orthognathic Surgical Kit Due to Labeling Error
FDA (Devices) · 2020-03-25
- ModerateMaterialise Recalls TRUMATCH Orthognathics Genioplasty Surgical Kit Due to Labeling Error
FDA (Devices) · 2020-03-25
Same hazard · incorrect patient data
See all →- HighGE Healthcare Recalls Centricity Universal Viewer 6.0 Software
FDA (Devices) · 2019-07-10
- HighGE Healthcare Recalls Centricity PACS Foundation Software
FDA (Devices) · 2019-07-10
- HighMaterialise Recalls Patient-Specific Orthognathic Surgical Guides Due to Incorrect Case Reports
FDA (Devices) · 2014-01-01
- HighMaterialise Recalls Patient-Specific Orthognathic Surgical Guides Due to Incorrect Case Reports
FDA (Devices) · 2014-01-01
- HighGE Centricity PACS-IW Software Recall for Patient Safety Risks
FDA (Devices) · 2013-11-06