FDA Recall
Completed
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 procedures. Identification number: SD900.101
Recall: Z-2287-2023
·
Initiated June 19, 2023
Recall
- Recall Number
- Z-2287-2023
- Event Number
- 92732
- Firm
- Materialise N.V. Technologielaan 15 Heverlee Belgium
- FEI Number
- 3003998208
- Product Code
- JEY
- Status
- Completed
- Root Cause
- Process change control
- Initiated
- June 19, 2023
- Posted
- August 3, 2023
Description
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 procedures. Identification number: SD900.101
Reason
Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request
Action
Synthes sales representative was made aware of the issue on 19 June 2023, by phone and email. Materialise requested the product to be returned on 19 June 2023, Synthes sales representative confirmed that surgery will be performed without guides and will return the case. The guides were returned/received at Materialise on 23 June 2023.
Distribution
US Nationwide distribution in the state of KY.
Quantity
1 unit