MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032
Recall
- Recall Number
- Z-0715-2022
- Event Number
- 89458
- Firm
- Stryker Leibinger GmbH & Co. KG Botzinger Str. 41 Freiburg Im Breisgau Germany
- FEI Number
- 3002821504
- Product Code
- FTM
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- December 29, 2021
- Terminated
- December 21, 2023
Description
MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032
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.
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 [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 +1 800 962-6558.
Worldwide distribution - US Nationwide.
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