Materialise N.V. recall records

0 reported ongoing

2 records in this archive. Latest source date Jun 19, 2023.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone and/or guide surgical instruments in mandibular and maxillofacial surgical pr...

Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request

Class IIReported completed

Distribution: US Nationwide distribution in the state of KY.

Official source for ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bo...
FDA device enforcement

MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific Instruments (PSI)-- patient-matched device designed to fit the patients anatomy to transfer a pa...

The wrong tibia guide was included intended for a different patient case.

Class IIReported completed

Distribution: International Distribution to countries of: Germany, Netherlands

Official source for MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific Instruments (PSI...

Reasons in these listed records

  • Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request
  • The wrong tibia guide was included intended for a different patient case.

These examples come from this result page and are not a ranking of every recall reason.

Checking Materialise N.V.

Is there a recall on materialise n.v. right now?

This archive contains 2 records, including 0 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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