MEDPOR TITAN recallZ-0715-2022 · Stryker Leibinger GmbH & Co. KG · initiated Dec 29, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Stryker Leibinger GmbH & Co. KG or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-0715-2022
- Status
- Terminated
- Initiated by the company
- Dec 29, 2021
- Recalling firm
- Stryker Leibinger GmbH & Co. KG
- Quantity
- 74
- Product code
- FTM
- FDA submissions
- K040364
- Distribution
- Worldwide distribution - US Nationwide.
Product description
MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032
Code information (models, lots, serial numbers)
UDI: 07613252084334; Lot Number: 3R7YHD
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- MEDPOR TITAN 81032Stryker Leibinger GmbH & Co. KG · Mesh, surgical1 recall1 report
Product lines
Other devices under the same FDA submission
3 devices cleared under K040364 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- MEDPOR TITAN 81033Stryker Leibinger GmbH & Co. KG · Mesh, surgical2 reports
- MEDPOR TITAN 81024Stryker Leibinger GmbH & Co. KG · Mesh, surgical1 report
- MEDPOR TITAN 81029Stryker Leibinger GmbH & Co. KG · Mesh, surgical1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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