Stryker recalls MEDPOR Titan OFW - MTB Right 1.0mm implants with a packaging error where the barrier layer is on the wrong side. This could affect surgical placement. Check your implant's UDI and lot number.
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.
Take action
Contact the company
📍Recalling firmStryker Leibinger GmbH & Co. KGBotzinger Str. 41 · Freiburg Im Breisgau, Germany
“Stryker MEDPOR Titan OFW - MTB Right 1.0mm Recall: Packaging Error.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61330-stryker-medpor-titan-ofw-mtb-right-1-0mm-recall-packaging. Based on FDA recall #Z-0715-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0715-2022%22&limit=1).
The FDA announced on Dec. 29, 2021, that Stryker Leibinger GmbH & Co. KG voluntarily recalled MEDPOR Titan OFW - MTB - Right - 1.0mm implants due to a manufacturing defect. The hazard involves the barrier layer being manufactured on the inferior side of the implant rather than the superior side as designed.
How to tell if you have it
Brand: Stryker
Product: MEDPOR Titan OFW - MTB - Right - 1.0mm
Catalog number: 81032
UDI: 07613252084334
Lot Number: 3R7YHD
The hazard
The FDA stated that inside the packaging of one reported item, a non-conforming product was found. The barrier layer was manufactured on the inferior side of the implant versus the superior side.
Context
GovInfoNow's records show Stryker Leibinger GmbH & Co. KG has five other recalls on record since June 22, 2018. Other recent recalls include Stryker Scopis ENT Software Version NOVA 3.6.0 RC16 (April 4, 2024), Stryker 1.5/1.7MM Dynamic Mesh Recall (March 29, 2024), and Stryker TMJ Reconstruction Prosthesis Recall (Dec. 6, 2022). Other recent recalls of similar products include Straumann GM Helix Dental Implant Recall (July 13, 2026) and Encore Medical EMPOWR 3D Knee Tibial Insert 5R 14MM Recall (Jan. 5, 2026).
How to tell if you have this one
Check your implant's Unique Device Identification (UDI) number and lot number. The affected model is MEDPOR Titan OFW - MTB - Right - 1.0mm with UDI 07613252084334 and lot number 3R7YHD.
Brand
Stryker
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Your Implant Details
Identify your implant's UDI number and lot number to confirm if it matches the recalled model.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 2 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The recall does not require immediate action for patients who have already received the implant. However, you should verify your implant details to ensure it matches the recalled model.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0715-2022 (December 29, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0715-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.