Materialise USA recalls

Materialise USA has 6 recalls on record with the FDA and USDA, the earliest in 2014 and the latest reported on 31 Aug 2022.

Total recalls6since 2014

Last 12 months0reported

Class I00% of total

Ongoing0latest 31 Aug 2022

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 6 100%Class III 0 0%

Why materialise usa is recalled

Product types

By year

2022117%
2016117%
2014467%

All materialise usa recalls, newest first

6 total

Reported	Class	Recall	Company	Reason	Where
31 Aug 2022Device	CLASS II	ProPlan CMF Anatomical recalled by Materialise USA	Materialise USA	Other	Nationwide
15 Jun 2016Device	CLASS II	Signature TKA GDE/MDL Set 04-05 Patient-specific surgical recalled	Materialise USA	Device Malfunction	IN
3 Dec 2014Device	CLASS II	Zimmer Patient Specific Instrument Persona CR Pin Guides recalled	Materialise USA	Nitrosamine Impurity	Nationwide
15 Jan 2014Device	CLASS II	REF 42-411571 QTY 1 Catalog Caution. SEE Instructions FOR USE recalled	Materialise USA	Sterility	MO
1 Jan 2014Device	CLASS II	ProPlan CMF Guide(s) recalled by Materialise USA	Materialise USA	Other	MI
1 Jan 2014Device	CLASS II	ProPlan CMF Guide(s) recalled by Materialise USA	Materialise USA	Other	MI

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.