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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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…
- 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.
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