Recall Z-1785-2024— Stryker Leibinger GmbH & Co. KG

Name: FDA recall Z-1785-2024
Creator: U.S. Food and Drug Administration
Published: 2024-03-29

Class II · Ongoing

Class II FDA medical device recall by Stryker Leibinger GmbH & Co. KG, initiated 2024-03-29. It names one FDA 510(k) clearance: K182425. 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: Mislabeled: Product labeled 56-90614 (90x90 Gold Mesh), was actually 56-90314 (90x90 Blue Mesh), may cause a delay in procedure.

Recalling firm: Stryker Leibinger GmbH & Co. KG
Classification: Class II
Status: Ongoing
Initiated: 2024-03-29
Firm location: Freiburg Im Breisgau, N/A, Germany

510(k) clearances named in this recall

1 on FDA's record

K182425 — Universal Mesh - SterileStryker Leibinger GmbH & Co KG·cleared 2018-11-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.