FDA Medical Device Recalls (openFDA)
Stryker Leibinger GmbH & Co. KG: MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032
- Recall number
- Z-0715-2022
- Recalling firm
- Stryker Leibinger GmbH & Co. KG
- Product
- MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032
- Status
- Terminated
- Initiated
- 2021-12-29
- Posted
- not on file
- Terminated
- 2023-12-21
- 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 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
- 74
- Distribution
- Worldwide distribution - US Nationwide.
- Lot, serial or model codes
- UDI: 07613252084334; Lot Number: 3R7YHD
- 510(k) numbers
- ["K040364"]
- PMA numbers
- not on file
- Product code
- FTM
- Firm FEI
- 3002821504
- Firm city
- Freiburg Im Breisgau
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28