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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker 1,5/1,7MM DYNAMIC MESH STDMEDIUM; Universal MeshSterile

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  Class 2 Device Recall Stryker 1,5/1,7MM DYNAMIC MESH STDMEDIUM; Universal MeshSterile see related information
Date Initiated by Firm March 29, 2024
Date Posted May 08, 2024
Recall Status1 Open3, Classified
Recall Number Z-1785-2024
Recall Event ID 94367
510(K)Number K182425  
Product Classification Plate, cranioplasty, preformed, alterable - Product Code GWO
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
Code Information GTIN: 07613327123197 Lot Number: 270644
Recalling Firm/
Manufacturer		 Stryker Leibinger GmbH & Co. KG
Botzinger Str. 41
Freiburg Im Breisgau Germany
For Additional Information Contact SAME
+4976145120 Ext. 0
Manufacturer Reason
for Recall		 Mislabeled: Product labeled 56-90614 (90x90 Gold Mesh), was actually 56-90314 (90x90 Blue Mesh), may cause a delay in procedure
FDA Determined
Cause 2		 Under Investigation by firm
Action 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 CMF-custserv1@stryker.com 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.
Quantity in Commerce 63 units
Distribution Nationwide
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = GWO and Original Applicant = Stryker Leibinger GmbH & Co. KG
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