Recall Z-2287-2023 ยท JEY Plate, Bone
Materialise N.V.
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
| Date | Aug 3, 2023 (initiated Jun 19, 2023) |
| Status | Completed |
| Reason | Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request |
| Root cause | Process change control |
| 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. |
| Quantity | 1 unit |
| Distribution | US Nationwide distribution in the state of KY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103136 | SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDE Materialise NV, Mar 18, 2011 |