Device product
Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction, stabilization and rigid fixation of the bony areas of the cranial skeleton. Catalog Number: 56-90614
Z-1785-2024
Product summary
- Event
- Event 94367
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 63 units
- Official record key
device-enforcement:Z-1785-2024
Official wording
Reason: Mislabeled: Product labeled 56-90614 (90x90 Gold Mesh), was actually 56-90314 (90x90 Blue Mesh), may cause a delay in procedure
Code information: GTIN: 07613327123197 Lot Number: 270644
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
Mislabeled