Recall Z-0715-2022 ยท FTM Mesh, Surgical
Stryker Leibinger GmbH & Co. KG
MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032
| Date | Dec 29, 2021 |
| Status | Terminated |
| Reason | Inside the packaging of one reported item a non-conforming product was found. Contrary to the design, the barrier layer was manufactured on the inferior side of the implant versus the superior side. |
| Root cause | Process control |
| Action | An URGENT MEDICAL DEVICE Recall notification letter dated 12/29/21 was sent to customers. Actions needed 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-custserv@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 fac |
| Quantity | 74 |
| Distribution | Worldwide distribution - US Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040364 | MEDPOR CRANIOFACIAL IMPLANTS WITH EMBEDDED TITANIUM MESH Porex Surgical, Inc., Jun 30, 2004 |