Z-1785-2024 Class II Ongoing
FDA device recall Z-1785-2024 was initiated by Stryker Leibinger GmbH & Co. KG on March 29, 2024 and is designated Class II. Reason for recall: Mislabeled: Product labeled 56-90614 (90x90 Gold Mesh), was actually 56-90314 (90x90 Blue Mesh), may cause a delay in procedure The recall status is ongoing. Affected quantity: 63 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 15, 2024
- Initiation Date
- March 29, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 63 units
Product 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 for Recall
Mislabeled: Product labeled 56-90614 (90x90 Gold Mesh), was actually 56-90314 (90x90 Blue Mesh), may cause a delay in procedure
Distribution Pattern
Nationwide
Code Information
GTIN: 07613327123197 Lot Number: 270644