Materialise Recalls Patient-Specific Knee Surgical Guides Due to Alignment Inaccuracies
Materialise N.V. is recalling four patient-specific surgical guides for knee arthroplasty because image data processing errors led to inaccurate surgical planning.
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 high-risk medical device where a defect (inaccurate surgical planning) poses a risk of harm, but the source text does not explicitly report any injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Materialise N.V. is recalling four units of Signature Patient-Specific Surgical Guides. These instruments are used as guides during total and partial knee arthroplasty procedures and are part of the Signature Personalized Patient Care System.
The recall was initiated because the patient image data was incorrectly processed, resulting in potential inaccuracies in the alignment of the guides. This error caused the surgery to be inaccurately planned.
The affected units were distributed in Michigan, Idaho, Texas, and France. Healthcare providers and patients who have used these specific guides should contact Materialise N.V. for further instructions.
The recalled product
- Product
- Signature Patient-Specific Surgical Guides; patient specific instruments used as a guide during surgical procedure for total and partial knee arthroplasty. Part of the Signature Personalized Patient Care System.
- Manufacturer
- Materialise N.V.
- Category
- Medical Device — Surgical Guides
- Affected units
- 4
Distribution
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