FDAClass IIMay 15, 2024

Stryker 1 recall: Labeling Error

Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction, stabilization and rigid fixation of the bony areas of the cranial…

Why was Stryker 1 recalled?

Mislabeled: Product labeled 56-90614 (90x90 Gold Mesh), was actually 56-90314 (90x90 Blue Mesh), may cause a delay in procedure

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

GTIN: 07613327123197 Lot Number: 270644

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…
Recalling firm
Stryker Leibinger GmbH & Co. KG
Quantity
63 units
Distribution
Nationwide
Recall date
May 15, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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