Materialise Recalls Patient-Specific Knee Surgical Guide Set Due to Fit Error
Materialise USA LLC is recalling a patient-specific knee surgical guide set because the femur guide does not match the patient, preventing proper use during surgery.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where a defect could lead to improper fit and inability to use the guide during surgery, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Materialise USA LLC is recalling one unit of the Signature TKA GDE/MDL Set 04-05, a patient-specific surgical guide and instrument set. The recall is due to a specific case where the included femur guide does not match the patient associated with the case.
If this 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. The product was distributed to one consignee in Indiana.
The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled item.
The recalled product
- Product
- Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument set.
- Manufacturer
- Materialise USA LLC
- 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 #154970
Distribution
Distributed in 1 state:
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