ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone and/or guide surgica
FDA device recall Z-2287-2023 · posted 2023-08-03 · Completed
Recall details
- Recalling firm
- Materialise N.V.
- Reason for recall
- Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request
- Action taken
- 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.
- Root cause
- Process change control
- Status
- Completed
- Product code
- JEY
- Quantity affected
- 1 unit
- Distribution
- US Nationwide distribution in the state of KY.
- Date initiated
- 2023-06-19
- Date posted
- 2023-08-03
- Location
- Heverlee, Belgium
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDE (K103136) | Materialise NV | 2011-03-18 |