Device product

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

Z-0715-2022

December 29, 2021

Class II

Product summary

Firm: Stryker Leibinger GmbH & Co. KG
Event: Event 89458
Status: Terminated
Classification: Class II
Quantity: 74
Official record key: device-enforcement:Z-0715-2022

Official wording

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.

Code information: UDI: 07613252084334; Lot Number: 3R7YHD

Distribution pattern: Worldwide distribution - US Nationwide.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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.