Materialise USA, LLC.
United Statesfrom the FDA registration address FDA establishment FEI 3005718816
- Devices
- 0
- Registrations
- FDA
- FDA recalls
- 8
Company details
- FDA FEI number
- 3005718816
- Address
- 44650 Helm Court, Plymouth, MI, 48170
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 1
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2022
- 13 Jul 2022 Z-1569-2022 Class II Completed MU22-INA-DUQ case was labeled as MU22-INA-DUQ but was shipped with the Anatomical Model of case MU22-NOF-SAK
2016
- 3 May 2016 Z-1941-2016 Class II Terminated A patient specific case of Signature Personalized Patient Care System Knee Guides included a femur guide which does not match the patient associated with the case. If the 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.
2014
- 16 Oct 2014 Z-0418-2015 Class II Terminated The box of guides for a specific case arrived intact but contained two (2) femoral guides instead of one (1) femoral guide and one (1) tibial guide. The device did not meet specification: One tibia guide missing and one femur guide contained an edge which was +0.04 mm over specification.
2013
- 26 Nov 2013 Z-0628-2014 Class II Terminated Shipped femur guide contained a non-conformance which could possibly impact fit of the drill insert.
- 8 Nov 2013 Z-0577-2014 Class II Terminated Patient Specific Guide contained the incorrect case report. The case report contains patient specific surgical plan information.
- 8 Nov 2013 Z-0578-2014 Class II Terminated Patient Specific Guide contained the incorrect case report. The case report contains patient specific surgical plan information.
2012
- 23 Mar 2012 Z-1543-2012 Not yet classified Terminated March 23, 2012 a field representative reported patient specific -0242-L tibia guide case packaging contained a different patient specific -0864-R tibia guide. The two patient specific products had been switched in packaging. Neither products had been delivered to the end user.
- 23 Mar 2012 Z-1544-2012 Not yet classified Terminated March 23, 2012 a field representative reported patient specific --0242 L tibia guide case packaging contained a different patient specific ..-0864-R tibia guide. The two patient specific products had been switched in packaging. Neither products had been delivered to the end user.