Who should I contact about this recall?

Contact Stryker Leibinger GmbH & Co. KG directly, or the distributor/pharmacy that supplied the product, to confirm whether your specific lot or unit is affected. Argus HQ aggregates the public FDA recall record and is not the recalling firm.

Has Stryker Leibinger GmbH & Co. KG had other FDA recalls or enforcement actions?

Yes. Argus HQ has recorded 3 total FDA actions tied to Stryker Leibinger GmbH & Co. KG, including 3 recalls and 0 warning letters.

FDA Recall Database: Class II Recall: Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction,… by Stryker Leibinger GmbH & Co. KG

Here's the summary: FDA classified a recall by Stryker Leibinger GmbH & Co. KG as Class II, reported 20240515. The affected product is 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 number Z-1785-2024). Reason for recall: Mislabeled: Product labeled 56-90614 (90x90 Gold Mesh), was actually 56-90314 (90x90 Blue Mesh), may cause a delay in procedure. Status: Ongoing. A Class II recall is FDA’s middle classification. FDA assigns Class II when use of, or exposure to, the recalled product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. FDA still requires the recalling firm to notify affected accounts and submit status reports on the correction, though the monitoring intensity is lower than for a Class I recall.

Key facts

Recalling firm	Stryker Leibinger GmbH & Co. KG
Manufacturer	Not disclosed in the FDA record.
Brand name	Not disclosed in the FDA record.
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
Classification	Class II
Recall number	Z-1785-2024
Report date	Not disclosed in the FDA record.
Status	Ongoing
Reason for recall	Mislabeled: Product labeled 56-90614 (90x90 Gold Mesh), was actually 56-90314 (90x90 Blue Mesh), may cause a delay in procedure

What consumers should do

Facilities, clinicians, and consumers holding an affected unit or lot 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 Number: 56-90614 should stop using it for the purpose described in the recall notice and hold remaining stock pending instructions from Stryker Leibinger GmbH & Co. KG. FDA recall records typically direct the recalling firm to notify known accounts directly with a recall letter describing the specific corrective action -- replacement, field correction, refund, or return. Anyone who received the product through a distributor rather than directly from Stryker Leibinger GmbH & Co. KG should confirm with their supplier whether their specific lot or unit is on the affected list, since recall notices are lot- or unit-specific and not every unit of a product line is necessarily included. Questions about a specific unit's status should go to Stryker Leibinger GmbH & Co. KG directly or to the distributor that supplied it; Argus HQ is a public-record aggregator, not the recalling firm, and cannot confirm individual unit status.

What this classification means

A Class II recall is FDA’s middle classification. FDA assigns Class II when use of, or exposure to, the recalled product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. FDA still requires the recalling firm to notify affected accounts and submit status reports on the correction, though the monitoring intensity is lower than for a Class I recall. FDA's Center for Devices and Radiological Health (for devices) or Center for Drug Evaluation and Research (for drugs) reviews the classification and can require additional corrective action if the initial response is judged insufficient. Because this record is filed as Class II, professionals and consumers handling an affected lot should treat FDA's own classification -- not this page's summary of it -- as the authoritative risk signal. A Class I recall is FDA’s most serious classification. FDA assigns Class I when there is a reasonable probability that use of, or exposure to, the recalled product will cause serious adverse health consequences or death. This classification does not mean harm has already occurred in every case -- it reflects FDA’s assessment of the realistic worst-case risk profile of the defect described in the recall, based on the reason for recall reported by the firm. Class I recalls receive the closest FDA monitoring of the three classes: the recalling firm typically must submit a recall strategy, periodic status reports, and effectiveness checks confirming that the affected lots have actually been removed from distribution or corrected in the field.

Stryker Leibinger GmbH & Co. KG’s FDA history

Argus HQ has recorded 3 total FDA actions tied to Stryker Leibinger GmbH & Co. KG: 0 warning letters, 3 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

Why was Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the recalled?: FDA's recall record states the reason as: Mislabeled: Product labeled 56-90614 (90x90 Gold Mesh), was actually 56-90314 (90x90 Blue Mesh), may cause a delay in procedure
Who should I contact about this recall?: Contact Stryker Leibinger GmbH & Co. KG directly, or the distributor/pharmacy that supplied the product, to confirm whether your specific lot or unit is affected. Argus HQ aggregates the public FDA recall record and is not the recalling firm.
Has Stryker Leibinger GmbH & Co. KG had other FDA recalls or enforcement actions?: Yes. Argus HQ has recorded 3 total FDA actions tied to Stryker Leibinger GmbH & Co. KG, including 3 recalls and 0 warning letters.
What is the FDA recall number for this event?: FDA recall number Z-1785-2024.

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Full FDA history for Stryker Leibinger GmbH & Co. KG

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2024). FDA Recall Database: Class II Recall: Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction,… by Stryker Leibinger GmbH & Co. KG. Digital Empire LLC. Retrieved from https://argushq.ai/recall/stryker-leibinger-and-kg-z-1785-2024-2024-05-15

MLA

"FDA Recall Database: Class II Recall: Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction,… by Stryker Leibinger GmbH & Co. KG." Argus HQ Research, Digital Empire LLC, 2024, argushq.ai/recall/stryker-leibinger-and-kg-z-1785-2024-2024-05-15.

Chicago

Argus HQ Research. "FDA Recall Database: Class II Recall: Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction,… by Stryker Leibinger GmbH & Co. KG." Digital Empire LLC. Accessed July 17, 2026. https://argushq.ai/recall/stryker-leibinger-and-kg-z-1785-2024-2024-05-15.

BibTeX

@misc{argushq_argushq_ai_recall_stryker_leibinger_and_kg_z_1785_2024_2024_05_15_2024,
  title = {FDA Recall Database: Class II Recall: Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction,… by Stryker Leibinger GmbH & Co. KG},
  author = {{Argus HQ Research}},
  year = {2024},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/recall/stryker-leibinger-and-kg-z-1785-2024-2024-05-15},
  note = {Accessed: July 17, 2026}
}

Source: FDA.gov — Recalls ↗