FDA Recall
Terminated
TRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on, Catalog Number: SD980.013
Recall: Z-1485-2020
·
Initiated February 3, 2020
Recall
- Recall Number
- Z-1485-2020
- Event Number
- 85080
- Firm
- Materialise N.V. Technologielaan 15 Heverlee Belgium
- FEI Number
- 3003998208
- Product Code
- JEY
- Status
- Terminated
- Root Cause
- Employee error
- Initiated
- February 3, 2020
- Terminated
- March 20, 2020
Description
TRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on, Catalog Number: SD980.013
Reason
Custom surgical kits contain a plate different than indicated by the package labeling.
Distribution
US: NY. OUS: Italy
Quantity
1