FDA Enforcement
Class II
Ongoing
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
Recall: Z-1785-2024
·
Reported May 15, 2024
Enforcement
- Recall Number
- Z-1785-2024
- Event ID
- 94367
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Stryker Leibinger GmbH & Co. KG
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 15, 2024
- Initiation Date
- March 29, 2024
- Classification Date
- May 8, 2024
- Address
- Botzinger Str. 41, N/A, Freiburg Im Breisgau, N/A, N/A, Germany
Description
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
Reason
Mislabeled: Product labeled 56-90614 (90x90 Gold Mesh), was actually 56-90314 (90x90 Blue Mesh), may cause a delay in procedure
Code Info
GTIN: 07613327123197 Lot Number: 270644
Distribution
Nationwide
Quantity
63 units