Z-0715-2022Class II

MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032

Name: Z-0715-2022 MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032
Creator: Stryker Leibinger GmbH & Co. KG
Published: 2021-12-29
License: https://open.fda.gov/license/

Stryker Leibinger GmbH & Co. KG / initiated 2021-12-29 / Terminated / root cause: manufacturing process

FDA source

Stryker Leibinger GmbH & Co. KG began a recall of MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032 on 2021-12-29. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0715-2022
Classification: Class II
Status: Terminated
Initiated: 2021-12-29
Posted: 2022-03-03
Terminated: 2023-12-21
Recalling firm: Stryker Leibinger GmbH & Co. KG
Product: MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032
Product code: FTM Mesh, Surgical
Reason for recall: 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 tag: manufacturing process
FDA 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 [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.
Quantity in commerce: 74
Distribution: Worldwide distribution - US Nationwide.
Product codes and lots: UDI: 07613252084334; Lot Number: 3R7YHD

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0715-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0715-2022	Class II	Terminated	Voluntary: Firm initiated	2022-03-09	2022-03-03

Product code FTM

K040364Class IIMedpor Craniofacial Implants with Embedded Titanium MeshPorex Surgical, Inc. / cleared 2004-06-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)