Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction, stabilization and rigid fixation of the bony
Summary
The FDA issued a Class II for Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction, stab by Stryker Leibinger GmbH & Co. KG. Reason: Mislabeled: Product labeled 56-90614 (90x90 Gold Mesh), was actually 56-90314 (90x90 Blue Mesh), may cause a delay in procedure.
Details
Source
Device Recall
External ID
Z-1785-2024
Action Date
2024-05-15
Status
Ongoing
Category
device
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
Lot/Code Info: GTIN: 07613327123197 Lot Number: 270644
Quantity Affected: 63 units
Reason for Recall
Mislabeled: Product labeled 56-90614 (90x90 Gold Mesh), was actually 56-90314 (90x90 Blue Mesh), may cause a delay in procedure
Distribution
Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2024-03-29
Company
Freiburg Im Breisgau, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 151 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Stryker Leibinger GmbH & Co. KG has 18 FDA actions in our database, including 4 recalls and 14 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Stryker Leibinger GmbH & Co. KG) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Stryker Leibinger GmbH & Co. KG have FDA actions?
Stryker Leibinger GmbH & Co. KG has 18 FDA actions in our database, including 4 recalls and 14 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1785-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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