Materialise Recalls Shipped Femur Guide Due to Fit Conformance Issue
Materialise USA LLC is recalling a specific lot of shipped femur guides from the Signature Personalized Patient Care System because a non-conformance could impact the fit of the drill insert.
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, and the source text describes a potential fit issue without reporting any injuries, illnesses, or hospitalizations, aligning with the criteria for moderate severity.
Plain-English summary
Materialise USA LLC is recalling a specific lot of shipped femur guides from the Signature Personalized Patient Care System. The product is a custom-made, non-sterile patient-specific instrument intended for use during total and partial knee arthroplasty procedures.
The recall was initiated because the shipped femur guide contained a non-conformance which could possibly impact the fit of the drill insert. The affected product is identified by Lot 094929 and was distributed only in Missouri.
The recalled product
- Product
- 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…
- Manufacturer
- Materialise USA LLC
- Hazard
- 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 094929
Distribution
Distributed in 1 state:
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