MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032
FDA Recall #Z-0715-2022 — Class II — December 29, 2021
Product Description
MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032
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.
Recalling Firm
Stryker Leibinger GmbH & Co. KG — Freiburg Im Breisgau
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
74
Distribution
Worldwide distribution - US Nationwide.
Code Information
UDI: 07613252084334; Lot Number: 3R7YHD
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated