Z-1785-2024Class II

Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction, stabilization and rigid fixation...

Name: Z-1785-2024 Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction, stabilization and rigid fixation...
Creator: Stryker Leibinger GmbH & Co. KG
Published: 2024-03-29
License: https://open.fda.gov/license/

Stryker Leibinger GmbH & Co. KG / initiated 2024-03-29 / Open, Classified / root cause: labeling and UDI

FDA source

Stryker Leibinger GmbH & Co. KG began a recall of 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... on 2024-03-29. FDA classified it as Class II and gives the reason as "Mislabeled: Product labeled 56-90614 (90x90 Gold Mesh), was actually 56-90314 (90x90 Blue Mesh), may cause a delay in procedure". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1785-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-03-29
Posted: 2024-05-08
Recalling firm: Stryker Leibinger GmbH & Co. KG
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
Product code: GWO Plate, Cranioplasty, Preformed, Alterable
Reason for recall: Mislabeled: Product labeled 56-90614 (90x90 Gold Mesh), was actually 56-90314 (90x90 Blue Mesh), may cause a delay in procedure
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Stryker issued Medical Device Recall Letter (Recall Number: # 3583053) via FedEx next day delivery on 03-28-2024 and 04-16-2024. Stryker sales representatives were notified via email on 03-28-2024. Letter states reason for recall, health risk and action to take: 1. Immediately check your internal inventory to locate the product listed on the attached business reply form. 2. Return the enclosed business reply form by email to [email protected] to confirm receipt of this notification. 3. Upon receipt of the completed business reply form, we will contact you to arrange for the return and replacement of your affected product(s). 4. Maintain awareness of this communication internally until all required actions have been completed within your facility. 5. Inform a Stryker representative if any of the subject devices have been distributed to other organizations. If so, provide contact details so that we may inform the recipients appropriately. If you have any questions or concerns, please contact Customer Service at +1 800 962-6558, Monday through Friday, 8:00 AM-7:00 PM Eastern Time.
Quantity in commerce: 63 units
Distribution: Nationwide
Product codes and lots: GTIN: 07613327123197 Lot Number: 270644

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1785-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1785-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-15	2024-05-08

Product code GWO

K182425Class IIUniversal Mesh - SterileStryker Leibinger GmbH & Co KG / cleared 2018-11-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)