Stryker Dynamic Mesh Mislabeled with Incorrect Catalog Number
Stryker shipped 63 units of cranial mesh labeled as catalog 56-90614 (Gold) but actually containing 56-90314 (Blue) mesh. The mislabeling may cause procedural delays.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a labeling error where the wrong catalog number was used on the packaging. No illnesses, injuries, or deaths have been reported. The hazard—procedural delay—is stated as potential rather than actual.
Plain-English summary
Stryker Leibinger GmbH & Co. KG has recalled 63 units of their 1.5/1.7MM Dynamic Mesh used for cranial reconstruction and fixation. The affected units were labeled with catalog number 56-90614 (90x90 Gold Mesh) but actually contained the different product type 56-90314 (90x90 Blue Mesh), lot number 270644.
The mislabeling creates a product identity discrepancy that may cause delays in surgical procedures. Healthcare facilities nationwide that received these units should verify that the actual contents match the labeling to ensure the correct product is used for intended surgical procedures.
The recalled product
- 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
- Manufacturer
- Stryker Leibinger GmbH & Co. KG
- Category
- Medical Device — Surgical Mesh
- Affected units
- 63
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- GTIN: 07613327123197 Lot Number: 270644
Distribution
Distributed nationwide across the United States.
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