Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the… recallZ-1785-2024 · Stryker Leibinger GmbH & Co. KG · initiated Mar 29, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Stryker Leibinger GmbH & Co. KG or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Mislabeled: Product labeled 56-90614 (90x90 Gold Mesh), was actually 56-90314 (90x90 Blue Mesh), may cause a delay in procedure
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-1785-2024
- Status
- Open, Classified
- Initiated by the company
- Mar 29, 2024
- Posted by the FDA
- May 8, 2024
- Recalling firm
- Stryker Leibinger GmbH & Co. KG
- Quantity
- 63 units
- Product code
- GWO
- FDA submissions
- K182425
- Distribution
- Nationwide
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
Code information (models, lots, serial numbers)
GTIN: 07613327123197 Lot Number: 270644
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- NA 56-90614Stryker Leibinger GmbH & Co. KG · Plate, cranioplasty, preformed, alterable1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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