FDA-Device2022-03-09Class II
MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032
Stryker Leibinger GmbH & Co. KG
Hazard
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.
Sold states
Worldwide distribution - US Nationwide.
Affected count
74
Manufactured in
Botzinger Str. 41, Freiburg Im Breisgau, Germany
Products
MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0715-2022Don't want to check this manually?
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