FDA recall Z-1785-2024

Stryker Leibinger GmbH & Co. KG · Class II · 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

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

Nationwide

Key facts

Status: Ongoing
Initiation date: 2024-03-29
Report date: 2024-05-15
Voluntary/Mandated: Voluntary: Firm initiated
Location: Freiburg Im Breisgau, N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1785-2024