Recall Z-1785-2024 ยท GWO Plate, Cranioplasty, Preformed, Alterable
Stryker Leibinger GmbH & Co. KG
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
| Date | May 8, 2024 (initiated Mar 29, 2024) |
| Status | Open, Classified |
| Reason | Mislabeled: Product labeled 56-90614 (90x90 Gold Mesh), was actually 56-90314 (90x90 Blue Mesh), may cause a delay in procedure |
| Root cause | 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 |
| Quantity | 63 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K182425 | Universal Mesh - Sterile Stryker Leibinger GmbH & Co KG, Nov 6, 2018 |