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.
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, 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 patient-specifi
- 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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